The effect of the Global Diet Quality Score (GDQS)-based diet on glycemic control , mental health and quality of life in patients with type 2 diabetes: a randomized controlled clinical trial

The effect of the Global Diet Quality Score (GDQS)-based diet on glycemic control , mental health and quality of life in patients with type 2 diabetes: a randomized controlled clinical trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol The effect of the Global Diet Quality Score (GDQS)-based diet on glycemic control , mental health and quality of life in patients with type 2 diabetes: a randomized controlled clinical trial Sara Bagherpour, Fatemeh Nourinezhad, Nasim Namiranian, Mohammad Afkhami-Ardekani, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4784239/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background As the most common endocrine disorder, type 2 diabetes is the main cause of more than 4% of deaths worldwide, West Asia and especially Iran is known as one of the regions in the world where the incidence of diabetes has increased significantly in recent years. Failure to control diabetes can cause side effects which reduce the patient's quality of life and increase mental disorders and the mortality rate.So dietary interventions such as a GDQS-based diet may be effective in improving biochemical and blood biomarkers and reducing risk factors in patients with type 2 diabetes. Methods This is a randomized clinical trial that includes men and women patients with type 2 diabetes. In total, 94 patients with type 2 diabetes were selected based on the entry criteria. Then these patients are randomly assigned to receive the diet based on GDQS (N = 47) or the standard diet of diabetic patients (N = 47) for 12 weeks. The primary outcomes will be the assessment of blood biomarkers (HbA1C, FBS, TG, TC, HDL, LDL) and mental health including (depression, anxiety), sleep quality and quality of life. Anthropometric measurements such as height, weight, waist circumference, body fat percentage, skeletal muscle percentage, body mass index and blood pressure will be considered as secondary outcomes. All outcomes will be measured at the beginning and end (end of 12 weeks) of the study. participants ' adherence will be evaluated using a 3-day food record (2 normal days and one off day) every week. Discussion Prospective studies have shown that adherence to healthy eating guidelines, as reflected by higher dietary quality indices, is associated with a lower risk of type 2 diabetes.A common feature among all diets is the consumption of more fruits, vegetables, and whole grains.Thus, a diet that scores high on the GDQS is associated with relatively plant-based diets.Among the foods in the GDQS, high consumption of red and processed meat, refined grains, sugar-sweetened beverages, and potatoes, especially french fries is associated with a higher risk of type 2 diabetes. However, more studies on GDQS-based diets in other populations are needed to confirm its usefulness in various populations to predict non-communicable diseases. Trial registration: Iranian Registry of Clinical Trials (www.irct.ir) IRCT20210427051098N4.Prospectively registered on December 1, 2023. Type 2 diabetes GDQS-based diet Nutritional status Mental health Lipid profile Figures Figure 1 Figure 2 Introduction As the most common endocrine disorder, type 2 diabetes is the main cause of more than 4% of deaths worldwide ( 1 ).The global prevalence of diabetes in adults in 2010 was 4.6%, equivalent to 285 million people, and in 2012, it was about 371 million people, which is estimated to reach more than 550 million people worldwide by 2030 ( 2 , 3 ).West Asia and especially Iran is known as one of the regions in the world where the incidence of diabetes has increased significantly in recent years ( 4 ).This disease, which is diagnosed with the symptoms of increased blood sugar and insulin resistance is related to the increased incidence of cardiovascular diseases, cancer and even mental disorders ( 5 ).Failure to control diabetes can cause side effects such as retinopathy, diabetic foot ulcers, neuropathy and nephropathy, which reduce the patient's quality of life and increase the mortality rate ( 6 ).It seems that considering the very important role of type 2 diabetes in increasing the burden of morbidity and mortality, knowing the risk factors related to the occurrence of this disease can be effective in increasing the level of health and quality of life of people in the society ( 6 ). The role of environmental exposures including improper diet ( 7 ), low physical activity ( 8 ), environmental pollution ( 9 ), diseases including obesity and hormonal disorders ( 10 ) in increasing the risk of type 2 diabetes have been investigated in previous studies and in this regard, several diets have been proposed to prevent or reduce the risk of type 2 diabetes.The Global Diet Quality Score (GDQS) includes 25 food groups and is used to predict the risk of non-communicable diseases and the adequacy of nutrient intake ( 11 ).The recommendation of this scoring is to consume higher amounts of whole grains, orange fruits and vegetables, legumes, fish, chicken, eggs, nuts, liquid oils and low-fat dairy products, as well as consuming lower amounts of red and processed meats, refined grains, sweets and drinks sweetened with sugar, fried foods that are prepared from outside, and limiting salt intake ( 11 ). Until now, the relationship between higher adherence to GDQS and lower prevalence of non-communicable diseases ( 11 ), obesity ( 12 ), increased waist circumference ( 13 ), metabolic syndrome ( 14 ), anemia ( 15 ), depression ( 16 ), congenital heart defects and type 2 diabetes ( 12 , 17 ) have been investigated ( 18 ).Clinical trial studies that have examined the effect of GDQS adherence on type 2 diabetes control are limited, and most of these studies have examined the short-term effects of consuming this diet on improving blood sugar control markers or other metabolic parameters ( 12 , 17 ).Also, only one study has investigated the effect of GDQS score on depression ( 16 ). So far, no clinical trial study has investigated the direct effects of following a training-(GDQS)-based diet on glycemic control and mental health in people with type 2 diabetes; Therefore, the present study is the first clinical trial study with the aim of investigating the effects of education-oriented diets based on high adherence to the global diet quality score compared to the standard diet on blood sugar control, mental health and anthropometric measurement in patients with type 2 diabetes is done for 12 weeks. Methods/design Study setting In this randomized clinical trial study, people with type 2 diabetes referred to Yazd Diabetes Research Center were placed in two groups (GDQS)-based diet and standard diet.In each group, there were 47 people with type 2 diabetes who were in the total number of people studied is 94 people with type 2 diabetes. The main purpose of this study is to investigate the effect of high adherence to (GDQS)-based diet compared to the standard diet on Blood levels of sugar indicators include hemoglobin A1C (HBA1C) and Fasting Blood Sugar (FBS), depression, anxiety, quality of life, sleep quality, and anthropometric measurement such as (height,weight, waist circumference, body fat percentage, skeletal muscle percentage, and body mass index)in people with type 2 diabetes. The secondary objectives of the study include assessment of blood pressure in people with type 2 diabetes.The trial protocol (IR) was approved by Shahid Sadoughi University of Medical Sciences' EthicsCommittee.( IR.SSU.SPH.REC.1402.104). Participants The target group of this study is people with type 2 diabetes, recruited from the Yazd Center for Diabetes. Inclusion criteria: Age ≥ 18 years Body mass index ≤ 40 kg / m2 Fasting blood sugar level ≥ 126 mg / dL Two-hour blood sugar ≥ 200 mg / dL Use of hypoglycemic drugs Exclusion criteria: Pregnancy Breastfeeding Uncontrolled diabetes (HbA1C >9 mg / dL) Nephropathy History or symptoms of ischemic heart disease Hospitalization for heart disease treatment within the past 6 months Cancer treatment within the past 5 years Proteinuria Steroid therapy during the last 3 months Thyroid disease History or symptoms of lung disease Adherence to a special diet Hepatitis Gastrointestinal disease Pancreatitis Inflammatory bowel disease Gastrointestinal ulcer AIDS or tuberculosis Acute mental disorders Syndrome Cushing's Drug abuse, Use of thiazide diuretics and use of antidepressants This study will use a demographic questionnaire to gather data on age, gender, economic status, education level, use of drugs/supplements,and family history of diseases after obtaining informed consent from those who meet the study's eligibility requirements.If necessary, the patient will be questioned vocally.The recruitment and randomization process is depicted in Fig. 1 . Sample size and power analysis The sample size based on the changes in hemoglobin A1C level during 12 weeks, considering the 95% confidence interval, at least 47 people in each group will be needed. According to similar previous studies and considering that no study has been done on the GDQS diet in this way, taking into account the first type error of 5% and the power of 80%, the sample size was calculated to be 42 people in each group, including 10% loss of 94 people. They will be randomly assigned to one of the intervention and control groups ( 19 ). Random Allocation Randomization based on gender (male and female) and BMI (higher and lower than 25) will be performed as stratified randomization with block size equal to 8 and 2 times. Allocation concealment method The group assigned to the people will be placed inside the sealed envelopes and then when the participant comes and after confirming the eligibility to enter the study, the envelope will be opened and placed in the designated group. Intervention GDQS group In the(GDQS)-based diet group, people with type 2 diabetes are trained the GDQS diet for 2 sessions (the first week after the intervention, and the last week before the end of the intervention) and each session lasts 30 minutes. People with type 2 diabetes will be randomly selected and placed in the standard or GDQS group. If there were two participants from the same family with type 2 diabetes, both would be randomly assigned to the standard or GDQS group. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict Eq. (20). If the body mass index is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy.The weight loss stage for overweight and obese people ends immediately after reaching a body mass index of less than 25 ( 21 ). Dietary recommendations based on GDQS will be adjusted according to the amount of energy needed by the person, which for a diet containing 1600 calories, 6–8 servings of fruits and vegetables per day, 7–8 servings of nuts and seeds per week, at least 6.5 daily servings of cereals ( Half of it should be whole grains), 2–3 daily servings of fat-free and low-fat dairy products, maximum 150 grams of meat (with an emphasis on fish and chicken), will be recommended. In training sessions, dietary recommendations based on GDQS will be fully explained to people. These recommendations will be based on the economic status and people's access to food and the status of some other diseases such as digestive diseases.Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call by using a 3-day food recall (2 normal days and one-off day). People are trained to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). Control standard diet group The amount of prescribed energy intake for people is calculated according to the Harris-Benedict Eq. (20). If the body mass index is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss stage for overweight and obese people ends immediately after reaching a body mass index of less than 25 ( 21 ). The control diet recommendations will be adjusted according to the amount of energy needed by the individual and will contain 55% carbohydrates, 15% protein, 30% fat and less than 5% energy from simple sugars.These recommendations will be based on the economic status and people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call by using a 3-day food recall (2 normal days and one-off day). The number of training sessions in the standard diet group will be 2 sessions (the first week after the intervention, and the last week before the end of the intervention) and healthy food recommendations will be taught to people. People are trained to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). People with type 2 diabetes are randomly placed in this group. Outcomes measures Blood samples will be taken after fasting for at least 8 hours and plasma markers including glycosylated hemoglobin(HbA1C),fasting blood sugar(FBS),triglyceride,total cholesterol,high-density lipoprotein (HDL) and low-density-lipoprotein (LDL) will be evaluated in people with type 2 diabetes at the beginning of the study and at the end of 12 weeks of intervention.The score of depression, anxiety, quality of life, sleep quality,anthropometric measurements such as(height,weight, waist circumference, body fat percentage, skeletal muscle percentage, and body mass index) and blood pressure will be checked at the beginning of the study and at the end of 12 weeks of intervention. The consumption of different medication, including blood sugar lowering drugs, blood pressure drugs, and herbal drugs will be evaluated at the beginning of the study and at the end of 12 weeks of intervention. The amount of physical activity of people will be evaluated at the beginning of the study and at the end of 12 weeks of intervention. Food intake for three days will also be evaluated 2 days at the beginning of the week and one day at the weekend, at the beginning of the study and at the end of 12 weeks of intervention.Also, in order to check the level of people's adherence to the diet, a phone call will be made once a week. The demographic information of the people and the socio-economic status of the people will be evaluated at the beginning of the study. It should be noted that all evaluations during the study will be the same for people in both groups. According to the nature of the study, the study the nutrition experts are aware of the type of educational intervention; But endocrinologists and laboratory experts are blind to the type of intervention in different people. Primary Study End Point Blood collection and biomarkers assessment (biochemical analysis) blood samples will be taken after fasting for at least 8 hours in the morning at the beginning of the study, and after 12 weeks from the beginning of the study. In the laboratory, 10 cc of venous blood samples will be taken from people using a venoject. (HbA1C),(FBS),triglyceride,total cholesterol,(HDL) and (LDL) will be evaluated at each appointment in people with type 2 diabetes. Assessment of Anxiety and Depression score The validated Beck questionnaire will be used to evaluate the state of depression and anxiety. Each depression and anxiety questionnaire has 21 questions and has a total score between 0 to 63 points ( 22 , 23 ).This questionnaire will be completed at the beginning of the study and after 12 weeks from the start of the intervention. Assessment of Sleep quality The validated questionnaires of Pittsburgh ( 24 ) and Berlin ( 25 ) will be used to evaluate the index of sleep quality and sleep apnea. The Pittsburgh Questionnaire has 7 scales, which are subjective quality of sleep, delay in falling asleep, duration of useful sleep, adequacy of sleep (ratio of duration of useful sleep to the time spent in bed), sleep disorders (waking up at night), amount of sleeping medication and it measures the disturbance in daily functioning (problems caused by insomnia during the day). The score of each scale is between 0 to 3, and the score of 3 in each scale indicates the maximum negative. Assessment of Quality of life :The SF-36 questionnaire, which has already been validated and validated in Persian language, to examine the quality of life of people in two scales: physical health such as (physical function, physical limitation, physical pain, and general health) and mental health such as (social function, mental problems, mental health, and vitality) will be used. The scores of each scale range from 0 to 100, where 0 is the worst and 100 is the best score in the scale in question ( 26 ). Assessment of Physical activity Physical activity will also be determined using the International Physical Activity Questionnaire(IPAQ). The questions in this questionnaire are about the times that the person was active in the last 7 days. This questionnaire contains 5 separate sections, each section has its own questions. The first part includes physical activity related to work, the second part includes questions about physical activity related to going from one place to another, the third part includes questions related to housework and home repair work, the fourth part includes sports in leisure time and finally The fifth includes questions about the time spent sitting. The international physical activity questionnaire will be completed in the form of an interview for all participants. According to the instructions for using the questionnaire, first the metabolic equivalent (MET) will be calculated in units of minutes per week.In summary, since one MET is equal to the resting energy expenditure of a person, physical activity can be classified as multiples of resting energy expenditure. The amount of MET is a certain amount based on the existing standards for each specific movement ( 27 ). Secondary study endpoints: Assessment of Blood pressure The blood pressure will be recorded by the nutrition expert at the beginning of the study and 12 weeks after the start of the intervention. At first, the person will be asked about the consumption of tea, coffee, physical activity and bladder fullness. Then people will rest for 10 minutes, and after that, the blood pressure will be measured from the right arm of the people in a sitting position, twice at least one minute apart, using a standard mercury sphygmomanometer with a cuff for adults with an accuracy of 5 mmHg. The average of two measurements will be calculated and considered as the final blood pressure. Systolic blood pressure is recorded when the first Krotkoff sound is heard, and diastolic blood pressure is recorded when the sound disappears (Krotkoff phase 5). All evaluations were done at least twice and the average of the two measurements will be recorded. Anthropometric measurements :Weight with minimal covering and without shoes will be measured and recorded by a nutrition expert using a digital scale with an accuracy of 100 grams. The height of people will be measured with a tape measure while standing next to the wall and without shoes, while the shoulders are in normal conditions, with an accuracy of one centimeter. Body mass index is calculated by dividing weight (in kilograms) by the square of height (in square meters). Waist circumference will be measured using an inflexible tape measure without imposing any pressure on the person's body with an accuracy of 0.5 cm. All evaluations were performed at least twice and the average of the two measurements will be recorded. Basal metabolic rate (BMR), total body fat percentage, skeletal muscle percentage, fat mass(FM), fat free mass(FFM) in total and segmental will be evaluated by Tanita BC- 418 body composition analyzer. Data Collection Method Demographic Data Collection A standard questionnaire will be used to evaluate the demographic information and economic status of people (age, gender, race, employment status, level of education, economic level). Assessment of medical history At the beginning of the study, people will be asked about their current disease status or history of specific and chronic diseases. After taking a detailed medical history, disease history, age at the time of diagnosis and treatment status of the person will be examined. Suffering from chronic diseases such as diabetes, hypertension, ischemic heart disease including heart failure and angina, kidney failure, fatty liver, hepatitis B, hepatitis C, epilepsy, chronic lung diseases (tuberculosis and asthma), thyroid problems, kidney stones, Gallstones, rheumatic diseases, lupus, gastrointestinal diseases such as inflammatory bowel disease or pancreatitis, history of gastrointestinal resection, neuropsychological problems, metabolic diseases, MS and various types of cancers, as well as treatment status will be examined.Individuals will be requested to inform the educational expert in case of any acute hypoglycemic problem. Assessment of dietary compliance Three-day food recall will be recorded on 2 days from the beginning of the week and one day from the weekend, which will be recorded weekly. Assessment of Medications : At the beginning of the study, the type of medication will be recorded by asking the patient to bring the medication ,the frequency of intake by asking the patient and the dosage according to the dosage indicated on the medication package. A) assessment of alcohol consumption: The question in this context is: “Have you ever drink alcoholic beverages?”; If the answer is yes, indicates the participant, the type of drink (percentage of alcohol) and the average amount consumed per time equals 30ml, one glass equals 150ml and one glass equals 250ml alcohol.B) assessment of smoking status: In this section, the person's smoking history and exposure to cigarette smoke will be asked first. The active smoking person refers to someone who is currently smoking. The age of smoking is also recorded in years. How many times a person smokes or smokes on average will be recorded in the person who has quit. Passive smoking was defined as a person who is indirectly exposed to cigarette smoke or is in the same environment with a smoker.C) assessment of other tobacco use : the person will be asked about other tobacco such as hookah or pipe, and the related table will be filled. In relation to drug use, the type of drug, method of use, frequency of use (daily, weekly, monthly, yearly) will be recorded. Statistical analysis In this study, data analysis using SPSS software. Ver. 20 will be done. The normal distribution of the data will be checked using histogram and Kolmogrov-Smirino test. Quantitative variables will be reported as mean ± standard deviation and qualitative variables will be reported as percentage. Repeated measures ANOVA and GEE longitudinal regression model will be used to investigate the effect of interventions on the research variables. P-value > 0.05 will be considered as a significant level. Ethics considerations The dietitian will explain the purpose, benefits or side effects of the study to all participants before obtaining written informed consent. Volunteers fill out a consent form and enroll in the study. You can revoke your consent at any time. According to previous studies, following this diet, as mentioned earlier, is safe and has no side effects. In case of acute clinical symptoms due to taking dietary supplements, subjects will be excluded from the study and the costs of possible complications will be borne by the researcher. Any side effects and other undesirable effects of experimental interventions are recorded and mentioned in the article. The personal data of registered participants will be collected, shared and kept confidential through encryption systems before, during and after the study. The results of the tests are available to the participants at the end. Participants are assured that the project does not charge fees for therapeutic interventions. Benefits of participating in this study for both groups: Performing laboratory tests and evaluating blood biomarkers such as HbA1C, fasting blood sugar, triglyceride, cholesterol, HDL, LDL for free at the beginning and end of the study. Nutritional advice and weekly monitoring Use of valid questionnaires to measure anxiety and depression, sleep quality,and quality of life at the beginning and end of the study. Assessment of Body composition and anthropometric measurements at the beginning and end of the study All results will be given to participants at the end of the study transmitted. Discussion Prospective studies from the United States ( 28 ), Europe ( 29 ), and Asia ( 30 , 31 ) have shown that adherence to healthy eating guidelines, as reflected by higher dietary quality indices, is associated with a lower risk of type 2 diabetes.Although in these studies, different quality diet indicators were used, such as healthy diet score, healthy eating index, alternative healthy eating index and some forms of Mediterranean diet, but the common features among them are the consumption of more fruits, vegetables and whole grains, protein without fat and less consumption of red and processed meat, added sugar and refined grains. The current global effort is to shift food consumption towards a more plant-based focus for human health ( 32 ).The GDQS has a total of 25 food groups and the food groups selected for the GDQS are implicitly consistent with this goal,of the 17 healthy food groups that should be emphasized in the diet, only 4 groups were of animal origin, and of the 9 unhealthy food groups to minimize consumption, 3 groups were animal protein and the group (sweets and ice cream) that often has a material of animal origin ( 11 ). Therefore, a diet that scores high on the GDQS is associated with relatively plant-based diets ( 11 ). GDQS-based diet includes two healthy and unhealthy sub-metrics ( 11 ).Less consumption of food in the unhealthy GDQS sub-metric (GDQS-) is associated with a lower risk of diabetes compared to the healthy GDQS sub-metric (GDQS+). Among the foods in the GDQS-, high consumption of red and processed meat ( 33 ), refined grains ( 34 ), sugar-sweetened beverages ( 34 ), and potatoes, especially french fries ( 35 ) is associated with a higher risk of type 2 diabetes.In addition, fried foods also increase the risk of type 2 diabetes ( 36 ). Fried foods may be due to their high energy content or increased lipid oxidation products ( 37 ) and trans fat ( 38 ) created during the frying process are a risk factor for diabetes. Red and processed meat may be involved in the pathogenesis of type 2 diabetes through the induction of proinflammatory advanced glycation end products ( 39 ) and pancreatic damage due to oxidative stress from heme iron ( 40 ). In addition, nitrites and nitrates in processed meats can be precursors for prooxidants to peroxynitrate ( 41 ). Refined grains and sugar-sweetened beverages may contribute to weight gain ( 42 ), and their high glycemic load is associated with diabetes risk ( 43 ). Healthy eating patterns are similar to the healthy sub-metric of GDQS (GDQS+) is inversely associated with diabetes ( 44 ).Because the GDQS is not specifically designed to predict diabetes risk, it does not include coffee ( 45 ) and moderate alcohol consumption in the metric score ( 46 ), both of which are inversely associated with type 2 diabetes. GDQS-based diet has an inverse relationship with type 2 diabetes and a good performance in predicting the risk of type 2 diabetes, and the results show that eating less junk food is more important than eating more healthy food. However, more studies on GDQS-based diet in other populations are needed to confirm its usefulness in a wide range of populations to predict non-communicable diseases. Trial status The testing status of the patient sampling phase is almost complete. The protocol is sent before the last patient. The first study participants enrolled on December 6, 2023 and the study is expected to be completed by April 24, 2024. Trial Registration: Clinical Trial Registration in Iran: IRCT20210427051098N4, registered on December 1, 2023. Abbreviations GDQS Global Diet Quality Score HBA1C Hemoglobin A1C FBS Fasting Blood Sugar HDL High-Density-lipoprotein LDL low-Density-lipoprotein IPAQ International Physical Activity Questionnaire MET Metabolic Equivalent FM Fat Mass FFM Fat Free Mass BMR Basal Metabolic Rate TC Total Cholesterol TG triglyceride BMI Body Mass Index WC Waist Circumference PCS Physical Component Summary MCS Mental Component Summary HRQOL Health-Related Quality of life QoL Quality of life SD Standard Deviation SPSS Statistical Package for Social Science Declarations Ethics approval and consent to participate The ethical committee Shahid Sadoughi of University of Medical Sciences in Yazd approved the written informed consent (code number:15653). The written informed consent was signed by all participants before the beginning study. Consent for publication Not applicable. Availability of data and materials The data and materials of the current study is available from the corresponding author on reasonable request. Competing interests The authors have declared no competing interests. Funding Shahid Sadoughi University of Medical Sciences supported this study. Author's contributions S.Kh: designed the study. S.Kh,S.B,F.N: conducted the study; S.B: wrote the manuscript and involved in the analysis. S.Kh: critically revised the manuscript; S.Kh: supervised the study. The final version of the manuscript was approved by all authors. Acknowledgments We acknowledge the contribution of the participants and co-researchers. Author's information 1 Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. 2 Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. 3 Yazd Diabetes Research Center , Yazd, Iran. References Kalaycı Z, Altun HK. 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Farrahi Moghaddam J, Nakhaee N, Sheibani V, Garrusi B, Amirkafi A. Reliability and validity of the Persian version of the Pittsburgh Sleep Quality Index (PSQI-P). Sleep and Breathing. 2012;16:79-82. Khaledi-Paveh B, Khazaie H, Nasouri M, Ghadami MR, Tahmasian M. Evaluation of Berlin questionnaire validity for sleep apnea risk in sleep clinic populations. Basic and clinical neuroscience. 2016;7(1):43. Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Quality of life research. 2005;14:875-82. Delshad M, Ghanbarian A, Ghaleh NR, Amirshekari G, Askari S, Azizi F. Reliability and validity of the modifiable activity questionnaire for an Iranian urban adolescent population. International journal of preventive medicine. 2015;6(1):3. Cespedes EM, Hu FB, Tinker L, Rosner B, Redline S, Garcia L, et al. Multiple healthful dietary patterns and type 2 diabetes in the Women's Health Initiative. American journal of epidemiology. 2016;183(7):622-33. Lacoppidan SA, Kyrø C, Loft S, Helnæs A, Christensen J, Hansen CP, et al. Adherence to a healthy Nordic food index is associated with a lower risk of type-2 diabetes—The Danish diet, cancer and health cohort study. Nutrients. 2015;7(10):8633-44. Chen G-C, Koh W-P, Neelakantan N, Yuan J-M, Qin L-Q, van Dam RM. Diet quality indices and risk of type 2 diabetes mellitus: the Singapore Chinese Health Study. American journal of epidemiology. 2018;187(12):2651-61. Yu D, Zheng W, Cai H, Xiang Y-B, Li H, Gao Y-T, et al. Long-term diet quality and risk of type 2 diabetes among urban Chinese adults. Diabetes Care. 2018;41(4):723-30. Willett W, Rockström J, Loken B, Springmann M, Lang T, Vermeulen S, et al. Food in the Anthropocene: the EAT–Lancet Commission on healthy diets from sustainable food systems. The lancet. 2019;393(10170):447-92. Micha R, Michas G, Mozaffarian D. Unprocessed red and processed meats and risk of coronary artery disease and type 2 diabetes–an updated review of the evidence. Current atherosclerosis reports. 2012;14:515-24. Schwingshackl L, Hoffmann G, Lampousi A-M, Knüppel S, Iqbal K, Schwedhelm C, et al. Food groups and risk of type 2 diabetes mellitus: a systematic review and meta-analysis of prospective studies. European journal of epidemiology. 2017;32:363-75. Schwingshackl L, Schwedhelm C, Hoffmann G, Boeing H. Potatoes and risk of chronic disease: a systematic review and dose–response meta-analysis. European journal of nutrition. 2019;58:2243-51. Cahill LE, Pan A, Chiuve SE, Sun Q, Willett WC, Hu FB, et al. Fried-food consumption and risk of type 2 diabetes and coronary artery disease: a prospective study in 2 cohorts of US women and men. The American journal of clinical nutrition. 2014;100(2):667-75. Shahidi F. Bailey's Industrial Oil and Fat Products, Industrial and Nonedible Products from Oils and Fats: John Wiley & Sons; 2005. Yang M, Yang Y, Nie S, Xie M, Chen F. Analysis and formation of trans fatty acids in corn oil during the heating process. Journal of the American Oil Chemists' Society. 2012;89(5):859-67. Uribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, et al. Advanced glycation end products in foods and a practical guide to their reduction in the diet. Journal of the American Dietetic Association. 2010;110(6):911-6. e12. Rajpathak SN, Crandall JP, Wylie-Rosett J, Kabat GC, Rohan TE, Hu FB. The role of iron in type 2 diabetes in humans. Biochimica et Biophysica Acta (BBA)-General Subjects. 2009;1790(7):671-81. Pacher P, Beckman JS, Liaudet L. Nitric oxide and peroxynitrite in health and disease. Physiological reviews. 2007;87(1):315-424. Malik VS, Hu FB. Sweeteners and risk of obesity and type 2 diabetes: the role of sugar-sweetened beverages. Current diabetes reports. 2012;12:195-203. Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. Jama. 2002;287(18):2414-23. Jayedi A, Soltani S, Abdolshahi A, Shab-Bidar S. Healthy and unhealthy dietary patterns and the risk of chronic disease: an umbrella review of meta-analyses of prospective cohort studies. British Journal of Nutrition. 2020;124(11):1133-44. Carlström M, Larsson SC. Coffee consumption and reduced risk of developing type 2 diabetes: a systematic review with meta-analysis. Nutrition reviews. 2018;76(6):395-417. Knott C, Bell S, Britton A. Alcohol consumption and the risk of type 2 diabetes: a systematic review and dose-response meta-analysis of more than 1.9 million individuals from 38 observational studies. Diabetes care. 2015;38(9):1804-12. Tables Table 1:Percentage of macronutrients in 1600 GDQS diet and 1600 control diet Macronutient 1600 Control 1600 GDQS CHO% 54% 50% Pr% 16% 20% Fat% 29% 30% Table 2: Comparison of GDQS scores based on specific food groups in two 1600 GDQS diet and 1600 Control diet 1600 Control 1600 GDQS Food Groups Consumed amounts(g/d) Point values Consumed amounts(g/d) Point values Citrus fruits 69 2 Deep orange fruits 123 2 Other fruits >107 2 >107 2 Dark green leafy vegetables >37 4 >37 4 Cruciferous vegetables <13 0 36 0.5 Deep orange vegetables 114 0.5 >114 0.5 legumes >42 4 >42 4 Deep orange tubers 12-63 0.25 >63 0.5 Nuts and Seeds 13 4 Whole Grain >13 2 >13 2 Liquid oils >7.5 2 >7.5 2 Fish and Shellfish 14-71 1 14-71 1 Poultry and Game meat >44 2 >44 2 Low fat dairy >132 2 >132 2 Eggs 6-32 1 >32 2 GDQS+ Score 20.75 30.75 High fat dairy <35 0 <35 0 Red meat 9-46 1 9-46 1 Processed meat <9 2 33 0 >33 0 Sweets and ice cream >37 0 <13 2 Sugar-sweetened beverages <57 2 <57 2 Juice <36 2 <36 2 White roots and tubers <27 2 <27 2 Purchased deep fried foods <9 2 <9 2 GDQS- Score 11 13 Overall 31.75 43.75 Additional Declarations No competing interests reported. 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Sciences","correspondingAuthor":false,"prefix":"","firstName":"Fatemeh","middleName":"","lastName":"Nourinezhad","suffix":""},{"id":334699102,"identity":"09a06bc9-e063-43cb-beb7-0ff8e125c856","order_by":2,"name":"Nasim Namiranian","email":"","orcid":"","institution":"Shahid Sadoughi University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Nasim","middleName":"","lastName":"Namiranian","suffix":""},{"id":334699104,"identity":"97dd761b-6442-4472-9233-fa5086fbc1f0","order_by":3,"name":"Mohammad Afkhami-Ardekani","email":"","orcid":"","institution":"Shahid Sadoughi University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohammad","middleName":"","lastName":"Afkhami-Ardekani","suffix":""},{"id":334699106,"identity":"6dc8aed1-4a32-49a7-9646-369e22294e12","order_by":4,"name":"Azadeh Nadjarzadeh","email":"","orcid":"","institution":"Shahid Sadoughi University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Azadeh","middleName":"","lastName":"Nadjarzadeh","suffix":""},{"id":334699107,"identity":"9f5e495c-1a8c-4699-8774-0bb2e022b851","order_by":5,"name":"Sara Jambarsang","email":"","orcid":"","institution":"Shahid Sadoughi University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Sara","middleName":"","lastName":"Jambarsang","suffix":""},{"id":334699108,"identity":"28f3c8e0-40c6-49ac-ab6e-01aa1b62c871","order_by":6,"name":"Sayyed Saeid Khayyatzadeh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+UlEQVRIiWNgGAWjYBACgxtwZgIbwwcgSVCL4QyITrAWxhnEaDGWQNLCzEOMFjPp5mfSPDV/7Pnbk489tm2zy+Nnb2D88DEHtxYbmWNm0jzHDJglzjxLN85tSy6W7DnALDlzGx4tEglALWwGbAw3csykc9uYEzfcALqQF48WM4n0b9I8/wx45G/kf5O2bKsnrMVYAmg4b5uBhMGNHDZpxrbDhLUYzsgptpzbZ2xgeOaZmWTPueOJM3sONuP1i8GN9I033nyTs5c7nvxM4kdZdWI/e/PBDx/xaAECFikeGJORDUw24FUPBMwff8DZfwgpHgWjYBSMgpEIADszUMXYsfKgAAAAAElFTkSuQmCC","orcid":"","institution":"Shahid Sadoughi University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Sayyed","middleName":"Saeid","lastName":"Khayyatzadeh","suffix":""}],"badges":[],"createdAt":"2024-07-22 20:18:57","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4784239/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4784239/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":63273210,"identity":"26981f68-086a-4be8-884d-36f0dbd32fa0","added_by":"auto","created_at":"2024-08-26 11:38:33","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":71904,"visible":true,"origin":"","legend":"\u003cp\u003eSummary of the patient flow diagram\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4784239/v1/dd9ffc7179bb2b176e17d439.jpg"},{"id":63273208,"identity":"9afeece8-221b-4f8f-ae12-ccfbd679ee0f","added_by":"auto","created_at":"2024-08-26 11:38:33","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":214432,"visible":true,"origin":"","legend":"\u003cp\u003eSPIRIT diagram of the recommended content for the schedule of enrolment, interventions, and assessments\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4784239/v1/8b43d67a0881c8a455c9d3ef.jpg"},{"id":65107589,"identity":"8c18700b-4c68-43f7-9fba-db69a9148536","added_by":"auto","created_at":"2024-09-23 17:01:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1037197,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4784239/v1/48f9f9c4-2d26-49fb-a246-865ad9b31b7a.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"The effect of the Global Diet Quality Score (GDQS)-based diet on glycemic control , mental health and quality of life in patients with type 2 diabetes: a randomized controlled clinical trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAs the most common endocrine disorder, type 2 diabetes is the main cause of more than 4% of deaths worldwide (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e).The global prevalence of diabetes in adults in 2010 was 4.6%, equivalent to 285\u0026nbsp;million people, and in 2012, it was about 371\u0026nbsp;million people, which is estimated to reach more than 550\u0026nbsp;million people worldwide by 2030 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).West Asia and especially Iran is known as one of the regions in the world where the incidence of diabetes has increased significantly in recent years (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).This disease, which is diagnosed with the symptoms of increased blood sugar and insulin resistance is related to the increased incidence of cardiovascular diseases, cancer and even mental disorders (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).Failure to control diabetes can cause side effects such as retinopathy, diabetic foot ulcers, neuropathy and nephropathy, which reduce the patient's quality of life and increase the mortality rate (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).It seems that considering the very important role of type 2 diabetes in increasing the burden of morbidity and mortality, knowing the risk factors related to the occurrence of this disease can be effective in increasing the level of health and quality of life of people in the society (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). The role of environmental exposures including improper diet (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), low physical activity (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), environmental pollution (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e), diseases including obesity and hormonal disorders (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) in increasing the risk of type 2 diabetes have been investigated in previous studies and in this regard, several diets have been proposed to prevent or reduce the risk of type 2 diabetes.The Global Diet Quality Score (GDQS) includes 25 food groups and is used to predict the risk of non-communicable diseases and the adequacy of nutrient intake (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).The recommendation of this scoring is to consume higher amounts of whole grains, orange fruits and vegetables, legumes, fish, chicken, eggs, nuts, liquid oils and low-fat dairy products, as well as consuming lower amounts of red and processed meats, refined grains, sweets and drinks sweetened with sugar, fried foods that are prepared from outside, and limiting salt intake (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Until now, the relationship between higher adherence to GDQS and lower prevalence of non-communicable diseases (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), obesity (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e), increased waist circumference (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e), metabolic syndrome (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), anemia (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), depression (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e), congenital heart defects and type 2 diabetes (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) have been investigated (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).Clinical trial studies that have examined the effect of GDQS adherence on type 2 diabetes control are limited, and most of these studies have examined the short-term effects of consuming this diet on improving blood sugar control markers or other metabolic parameters (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).Also, only one study has investigated the effect of GDQS score on depression (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). So far, no clinical trial study has investigated the direct effects of following a training-(GDQS)-based diet on glycemic control and mental health in people with type 2 diabetes; Therefore, the present study is the first clinical trial study with the aim of investigating the effects of education-oriented diets based on high adherence to the global diet quality score compared to the standard diet on blood sugar control, mental health and anthropometric measurement in patients with type 2 diabetes is done for 12 weeks.\u003c/p\u003e"},{"header":"Methods/design","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting\u003c/h2\u003e \u003cp\u003eIn this randomized clinical trial study, people with type 2 diabetes referred to Yazd Diabetes Research Center were placed in two groups (GDQS)-based diet and standard diet.In each group, there were 47 people with type 2 diabetes who were in the total number of people studied is 94 people with type 2 diabetes. The main purpose of this study is to investigate the effect of high adherence to (GDQS)-based diet compared to the standard diet on Blood levels of sugar indicators include hemoglobin A1C (HBA1C) and Fasting Blood Sugar (FBS), depression, anxiety, quality of life, sleep quality, and anthropometric measurement such as (height,weight, waist circumference, body fat percentage, skeletal muscle percentage, and body mass index)in people with type 2 diabetes. The secondary objectives of the study include assessment of blood pressure in people with type 2 diabetes.The trial protocol (IR) was approved by Shahid Sadoughi University of Medical Sciences' EthicsCommittee.( IR.SSU.SPH.REC.1402.104).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eThe target group of this study is people with type 2 diabetes, recruited from the Yazd Center for Diabetes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eInclusion criteria:\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eAge\u0026thinsp;\u0026ge;\u0026thinsp;18 years\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eBody mass index\u0026thinsp;\u0026le;\u0026thinsp;40 kg / m2\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eFasting blood sugar level\u0026thinsp;\u0026ge;\u0026thinsp;126 mg / dL\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTwo-hour blood sugar\u0026thinsp;\u0026ge;\u0026thinsp;200 mg / dL\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUse of hypoglycemic drugs\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003eExclusion criteria:\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003ePregnancy\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eBreastfeeding\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUncontrolled diabetes (HbA1C \u0026amp;gt;9 mg / dL)\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eNephropathy\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eHistory or symptoms of ischemic heart disease\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eHospitalization for heart disease treatment within the past 6 months\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eCancer treatment within the past 5 years\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eProteinuria\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eSteroid therapy during the last 3 months\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThyroid disease\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eHistory or symptoms of lung disease\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAdherence to a special diet\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eHepatitis\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eGastrointestinal disease\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePancreatitis\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eInflammatory bowel disease\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eGastrointestinal ulcer\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAIDS or tuberculosis\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAcute mental disorders\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eSyndrome Cushing's\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDrug abuse,\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUse of thiazide diuretics and use of antidepressants\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eThis study will use a demographic questionnaire to gather data on age, gender, economic status, education level, use of drugs/supplements,and family history of diseases after obtaining informed consent from those who meet the study's eligibility requirements.If necessary, the patient will be questioned vocally.The recruitment and randomization process is depicted in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eSample size and power analysis\u003c/h2\u003e \u003cp\u003eThe sample size based on the changes in hemoglobin A1C level during 12 weeks, considering the 95% confidence interval, at least 47 people in each group will be needed. According to similar previous studies and considering that no study has been done on the GDQS diet in this way, taking into account the first type error of 5% and the power of 80%, the sample size was calculated to be 42 people in each group, including 10% loss of 94 people. They will be randomly assigned to one of the intervention and control groups (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003eRandom Allocation\u003c/h2\u003e \u003cp\u003eRandomization based on gender (male and female) and BMI (higher and lower than 25) will be performed as stratified randomization with block size equal to 8 and 2 times.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003eAllocation concealment method\u003c/h2\u003e \u003cp\u003eThe group assigned to the people will be placed inside the sealed envelopes and then when the participant comes and after confirming the eligibility to enter the study, the envelope will be opened and placed in the designated group.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eIntervention GDQS group\u003c/h2\u003e \u003cp\u003eIn the(GDQS)-based diet group, people with type 2 diabetes are trained the GDQS diet for 2 sessions (the first week after the intervention, and the last week before the end of the intervention) and each session lasts 30 minutes. People with type 2 diabetes will be randomly selected and placed in the standard or GDQS group. If there were two participants from the same family with type 2 diabetes, both would be randomly assigned to the standard or GDQS group. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict Eq.\u0026nbsp;(20). If the body mass index is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy.The weight loss stage for overweight and obese people ends immediately after reaching a body mass index of less than 25 (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Dietary recommendations based on GDQS will be adjusted according to the amount of energy needed by the person, which for a diet containing 1600 calories, 6\u0026ndash;8 servings of fruits and vegetables per day, 7\u0026ndash;8 servings of nuts and seeds per week, at least 6.5 daily servings of cereals ( Half of it should be whole grains), 2\u0026ndash;3 daily servings of fat-free and low-fat dairy products, maximum 150 grams of meat (with an emphasis on fish and chicken), will be recommended. In training sessions, dietary recommendations based on GDQS will be fully explained to people. These recommendations will be based on the economic status and people's access to food and the status of some other diseases such as digestive diseases.Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call by using a 3-day food recall (2 normal days and one-off day). People are trained to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eControl standard diet group\u003c/h2\u003e \u003cp\u003eThe amount of prescribed energy intake for people is calculated according to the Harris-Benedict Eq.\u0026nbsp;(20). If the body mass index is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss stage for overweight and obese people ends immediately after reaching a body mass index of less than 25 (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The control diet recommendations will be adjusted according to the amount of energy needed by the individual and will contain 55% carbohydrates, 15% protein, 30% fat and less than 5% energy from simple sugars.These recommendations will be based on the economic status and people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call by using a 3-day food recall (2 normal days and one-off day). The number of training sessions in the standard diet group will be 2 sessions (the first week after the intervention, and the last week before the end of the intervention) and healthy food recommendations will be taught to people. People are trained to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). People with type 2 diabetes are randomly placed in this group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eOutcomes measures\u003c/h2\u003e \u003cp\u003eBlood samples will be taken after fasting for at least 8 hours and plasma markers including glycosylated hemoglobin(HbA1C),fasting blood sugar(FBS),triglyceride,total cholesterol,high-density lipoprotein (HDL) and low-density-lipoprotein (LDL) will be evaluated in people with type 2 diabetes at the beginning of the study and at the end of 12 weeks of intervention.The score of depression, anxiety, quality of life, sleep quality,anthropometric measurements such as(height,weight, waist circumference, body fat percentage, skeletal muscle percentage, and body mass index) and blood pressure will be checked at the beginning of the study and at the end of 12 weeks of intervention. The consumption of different medication, including blood sugar lowering drugs, blood pressure drugs, and herbal drugs will be evaluated at the beginning of the study and at the end of 12 weeks of intervention. The amount of physical activity of people will be evaluated at the beginning of the study and at the end of 12 weeks of intervention. Food intake for three days will also be evaluated 2 days at the beginning of the week and one day at the weekend, at the beginning of the study and at the end of 12 weeks of intervention.Also, in order to check the level of people's adherence to the diet, a phone call will be made once a week. The demographic information of the people and the socio-economic status of the people will be evaluated at the beginning of the study. It should be noted that all evaluations during the study will be the same for people in both groups. According to the nature of the study, the study the nutrition experts are aware of the type of educational intervention; But endocrinologists and laboratory experts are blind to the type of intervention in different people.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003ePrimary Study End Point\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eBlood collection and biomarkers assessment (biochemical analysis)\u003c/strong\u003e \u003cp\u003eblood samples will be taken after fasting for at least 8 hours in the morning at the beginning of the study, and after 12 weeks from the beginning of the study. In the laboratory, 10 cc of venous blood samples will be taken from people using a venoject. (HbA1C),(FBS),triglyceride,total cholesterol,(HDL) and (LDL) will be evaluated at each appointment in people with type 2 diabetes.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment of Anxiety and Depression score\u003c/strong\u003e \u003cp\u003eThe validated Beck questionnaire will be used to evaluate the state of depression and anxiety. Each depression and anxiety questionnaire has 21 questions and has a total score between 0 to 63 points (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e).This questionnaire will be completed at the beginning of the study and after 12 weeks from the start of the intervention.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment of Sleep quality\u003c/strong\u003e \u003cp\u003eThe validated questionnaires of Pittsburgh (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) and Berlin (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) will be used to evaluate the index of sleep quality and sleep apnea. The Pittsburgh Questionnaire has 7 scales, which are subjective quality of sleep, delay in falling asleep, duration of useful sleep, adequacy of sleep (ratio of duration of useful sleep to the time spent in bed), sleep disorders (waking up at night), amount of sleeping medication and it measures the disturbance in daily functioning (problems caused by insomnia during the day). The score of each scale is between 0 to 3, and the score of 3 in each scale indicates the maximum negative.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eAssessment of Quality of life\u003c/b\u003e :The SF-36 questionnaire, which has already been validated and validated in Persian language, to examine the quality of life of people in two scales: physical health such as (physical function, physical limitation, physical pain, and general health) and mental health such as (social function, mental problems, mental health, and vitality) will be used. The scores of each scale range from 0 to 100, where 0 is the worst and 100 is the best score in the scale in question (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment of Physical activity\u003c/strong\u003e \u003cp\u003ePhysical activity will also be determined using the International Physical Activity Questionnaire(IPAQ). The questions in this questionnaire are about the times that the person was active in the last 7 days. This questionnaire contains 5 separate sections, each section has its own questions. The first part includes physical activity related to work, the second part includes questions about physical activity related to going from one place to another, the third part includes questions related to housework and home repair work, the fourth part includes sports in leisure time and finally The fifth includes questions about the time spent sitting.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eThe international physical activity questionnaire will be completed in the form of an interview for all participants. According to the instructions for using the questionnaire, first the metabolic equivalent (MET) will be calculated in units of minutes per week.In summary, since one MET is equal to the resting energy expenditure of a person, physical activity can be classified as multiples of resting energy expenditure. The amount of MET is a certain amount based on the existing standards for each specific movement (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSecondary study endpoints:\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eAssessment of Blood pressure\u003c/strong\u003e \u003cp\u003eThe blood pressure will be recorded by the nutrition expert at the beginning of the study and 12 weeks after the start of the intervention. At first, the person will be asked about the consumption of tea, coffee, physical activity and bladder fullness. Then people will rest for 10 minutes, and after that, the blood pressure will be measured from the right arm of the people in a sitting position, twice at least one minute apart, using a standard mercury sphygmomanometer with a cuff for adults with an accuracy of 5 mmHg. The average of two measurements will be calculated and considered as the final blood pressure. Systolic blood pressure is recorded when the first Krotkoff sound is heard, and diastolic blood pressure is recorded when the sound disappears (Krotkoff phase 5). All evaluations were done at least twice and the average of the two measurements will be recorded.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eAnthropometric measurements\u003c/b\u003e:Weight with minimal covering and without shoes will be measured and recorded by a nutrition expert using a digital scale with an accuracy of 100 grams. The height of people will be measured with a tape measure while standing next to the wall and without shoes, while the shoulders are in normal conditions, with an accuracy of one centimeter. Body mass index is calculated by dividing weight (in kilograms) by the square of height (in square meters). Waist circumference will be measured using an inflexible tape measure without imposing any pressure on the person's body with an accuracy of 0.5 cm. All evaluations were performed at least twice and the average of the two measurements will be recorded. Basal metabolic rate (BMR), total body fat percentage, skeletal muscle percentage, fat mass(FM), fat free mass(FFM) in total and segmental will be evaluated by Tanita BC- 418 body composition analyzer.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eData Collection Method\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eDemographic Data Collection\u003c/strong\u003e \u003cp\u003eA standard questionnaire will be used to evaluate the demographic information and economic status of people (age, gender, race, employment status, level of education, economic level).\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment of medical history\u003c/strong\u003e \u003cp\u003eAt the beginning of the study, people will be asked about their current disease status or history of specific and chronic diseases. After taking a detailed medical history, disease history, age at the time of diagnosis and treatment status of the person will be examined. Suffering from chronic diseases such as diabetes, hypertension, ischemic heart disease including heart failure and angina, kidney failure, fatty liver, hepatitis B, hepatitis C, epilepsy, chronic lung diseases (tuberculosis and asthma), thyroid problems, kidney stones, Gallstones, rheumatic diseases, lupus, gastrointestinal diseases such as inflammatory bowel disease or pancreatitis, history of gastrointestinal resection, neuropsychological problems, metabolic diseases, MS and various types of cancers, as well as treatment status will be examined.Individuals will be requested to inform the educational expert in case of any acute hypoglycemic problem.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment of dietary compliance\u003c/strong\u003e \u003cp\u003eThree-day food recall will be recorded on 2 days from the beginning of the week and one day from the weekend, which will be recorded weekly.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eAssessment of Medications\u003c/b\u003e: At the beginning of the study, the type of medication will be recorded by asking the patient to bring the medication ,the frequency of intake by asking the patient and the dosage according to the dosage indicated on the medication package. A) assessment of alcohol consumption: The question in this context is: \u0026ldquo;Have you ever drink alcoholic beverages?\u0026rdquo;; If the answer is yes, indicates the participant, the type of drink (percentage of alcohol) and the average amount consumed per time equals 30ml, one glass equals 150ml and one glass equals 250ml alcohol.B) assessment of smoking status: In this section, the person's smoking history and exposure to cigarette smoke will be asked first. The active smoking person refers to someone who is currently smoking. The age of smoking is also recorded in years. How many times a person smokes or smokes on average will be recorded in the person who has quit. Passive smoking was defined as a person who is indirectly exposed to cigarette smoke or is in the same environment with a smoker.C) assessment of other tobacco use : the person will be asked about other tobacco such as hookah or pipe, and the related table will be filled. In relation to drug use, the type of drug, method of use, frequency of use (daily, weekly, monthly, yearly) will be recorded.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eIn this study, data analysis using SPSS software. Ver. 20 will be done. The normal distribution of the data will be checked using histogram and Kolmogrov-Smirino test. Quantitative variables will be reported as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation and qualitative variables will be reported as percentage. Repeated measures ANOVA and GEE longitudinal regression model will be used to investigate the effect of interventions on the research variables. P-value\u0026thinsp;\u0026gt;\u0026thinsp;0.05 will be considered as a significant level.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eEthics considerations\u003c/h2\u003e \u003cp\u003eThe dietitian will explain the purpose, benefits or side effects of the study to all participants before obtaining written informed consent. Volunteers fill out a consent form and enroll in the study. You can revoke your consent at any time. According to previous studies, following this diet, as mentioned earlier, is safe and has no side effects. In case of acute clinical symptoms due to taking dietary supplements, subjects will be excluded from the study and the costs of possible complications will be borne by the researcher. Any side effects and other undesirable effects of experimental interventions are recorded and mentioned in the article. The personal data of registered participants will be collected, shared and kept confidential through encryption systems before, during and after the study. The results of the tests are available to the participants at the end. Participants are assured that the project does not charge fees for therapeutic interventions. Benefits of participating in this study for both groups:\u003c/p\u003e \u003cul\u003e\n \u003cli\u003e\u003cem\u003ePerforming laboratory tests and evaluating blood biomarkers such as HbA1C, fasting blood sugar, triglyceride, cholesterol, HDL, LDL for free at the beginning and end of the study.\u003c/em\u003e\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eNutritional advice and weekly monitoring\u0026nbsp;\u003c/em\u003e\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eUse of valid questionnaires to measure anxiety and depression, sleep quality,and quality of life at the beginning and end of the study.\u003c/em\u003e\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eAssessment of\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/em\u003e\u003cem\u003eBody composition and anthropometric\u0026nbsp;\u003c/em\u003e\u003cem\u003emeasurements\u003c/em\u003e\u003cem\u003e\u0026nbsp;at the beginning and end of the study\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e \u003cp\u003eAll results will be given to participants at the end of the study transmitted.\u003c/p\u003e "},{"header":"Discussion","content":"\u003cp\u003eProspective studies from the United States (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e), Europe (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e), and Asia (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) have shown that adherence to healthy eating guidelines, as reflected by higher dietary quality indices, is associated with a lower risk of type 2 diabetes.Although in these studies, different quality diet indicators were used, such as healthy diet score, healthy eating index, alternative healthy eating index and some forms of Mediterranean diet, but the common features among them are the consumption of more fruits, vegetables and whole grains, protein without fat and less consumption of red and processed meat, added sugar and refined grains. The current global effort is to shift food consumption towards a more plant-based focus for human health (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e).The GDQS has a total of 25 food groups and the food groups selected for the GDQS are implicitly consistent with this goal,of the 17 healthy food groups that should be emphasized in the diet, only 4 groups were of animal origin, and of the 9 unhealthy food groups to minimize consumption, 3 groups were animal protein and the group (sweets and ice cream) that often has a material of animal origin (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Therefore, a diet that scores high on the GDQS is associated with relatively plant-based diets (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). GDQS-based diet includes two healthy and unhealthy sub-metrics (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).Less consumption of food in the unhealthy GDQS sub-metric (GDQS-) is associated with a lower risk of diabetes compared to the healthy GDQS sub-metric (GDQS+). Among the foods in the GDQS-, high consumption of red and processed meat (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e), refined grains (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e), sugar-sweetened beverages (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e), and potatoes, especially french fries (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e) is associated with a higher risk of type 2 diabetes.In addition, fried foods also increase the risk of type 2 diabetes (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). Fried foods may be due to their high energy content or increased lipid oxidation products (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) and trans fat (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) created during the frying process are a risk factor for diabetes. Red and processed meat may be involved in the pathogenesis of type 2 diabetes through the induction of proinflammatory advanced glycation end products (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) and pancreatic damage due to oxidative stress from heme iron (\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e). In addition, nitrites and nitrates in processed meats can be precursors for prooxidants to peroxynitrate (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). Refined grains and sugar-sweetened beverages may contribute to weight gain (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e), and their high glycemic load is associated with diabetes risk (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e). Healthy eating patterns are similar to the healthy sub-metric of GDQS (GDQS+) is inversely associated with diabetes (\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e).Because the GDQS is not specifically designed to predict diabetes risk, it does not include coffee (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e) and moderate alcohol consumption in the metric score (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e), both of which are inversely associated with type 2 diabetes. GDQS-based diet has an inverse relationship with type 2 diabetes and a good performance in predicting the risk of type 2 diabetes, and the results show that eating less junk food is more important than eating more healthy food. However, more studies on GDQS-based diet in other populations are needed to confirm its usefulness in a wide range of populations to predict non-communicable diseases.\u003c/p\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eThe testing status of the patient sampling phase is almost complete. The protocol is sent before the last patient. The first study participants enrolled on December 6, 2023 and the study is expected to be completed by April 24, 2024. Trial Registration: Clinical Trial Registration in Iran: IRCT20210427051098N4, registered on December 1, 2023.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGDQS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGlobal Diet Quality Score\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHBA1C\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHemoglobin A1C\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFBS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFasting Blood Sugar\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHDL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHigh-Density-lipoprotein\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLDL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003elow-Density-lipoprotein\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIPAQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternational Physical Activity Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMET\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMetabolic Equivalent\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFat Mass\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFFM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFat Free Mass\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBMR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBasal Metabolic Rate\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTotal Cholesterol\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTG\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003etriglyceride\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBMI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBody Mass Index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eWC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eWaist Circumference\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePhysical Component Summary\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMental Component Summary\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHRQOL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHealth-Related Quality of life\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eQoL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuality of life\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStandard Deviation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSPSS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStatistical Package for Social Science\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe ethical committee\u0026nbsp;Shahid Sadoughi of University of Medical Sciences in Yazd approved the written informed consent (code number:15653). The written informed consent was signed by all participants before the beginning study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data and materials of the current study is available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have declared no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eShahid Sadoughi University of Medical Sciences supported this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor\u0026apos;s contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eS.Kh: designed the study. S.Kh,S.B,F.N: conducted the study; S.B: wrote the manuscript and involved in the analysis. S.Kh: critically revised the manuscript; S.Kh: supervised the study. The final version of the manuscript was approved by all authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgments\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe acknowledge the contribution of the participants and co-researchers.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor\u0026apos;s information\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eDepartment of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.\u003csup\u003e2\u003c/sup\u003e Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.\u003csup\u003e3\u003c/sup\u003e Yazd Diabetes Research Center , Yazd, Iran.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eKalaycı Z, Altun HK. ARALIKLI A\u0026Ccedil;LIK DİYETLERİNİN GLUKOZ HOMEOSTAZI VE LİPİT METABOLİZMASI \u0026Uuml;ZERİNE ETKİLERİ. Bandırma Onyedi Eyl\u0026uuml;l \u0026Uuml;niversitesi Sağlık Bilimleri ve Araştırmaları Dergisi.3(1):52-63.\u003c/li\u003e\n\u003cli\u003eGuariguata L. By the numbers: new estimates from the IDF Diabetes Atlas Update for 2012. Diabetes research and clinical practice. 2012;98(3):524-5.\u003c/li\u003e\n\u003cli\u003eShaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes research and clinical practice. 2010;87(1):4-14.\u003c/li\u003e\n\u003cli\u003eMirahmadizadeh A, Fathalipour M, Mokhtari AM, Zeighami S, Hassanipour S, Heiran A. The prevalence of undiagnosed type 2 diabetes and prediabetes in Eastern Mediterranean region (EMRO): a systematic review and meta-analysis. Diabetes research and clinical practice. 2020;160:107931.\u003c/li\u003e\n\u003cli\u003eStumvoll M, Goldstein BJ, Van Haeften TW. 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Frontiers in nutrition. 2022;9:775543.\u003c/li\u003e\n\u003cli\u003eFrankenfield DC, Muth ER, Rowe WA. The Harris-Benedict studies of human basal metabolism: history and limitations. Journal of the American Dietetic Association. 1998;98(4):439-45.\u003c/li\u003e\n\u003cli\u003eJohansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, et al. Effect of an intensive lifestyle intervention on glycemic control in patients with type 2 diabetes: a randomized clinical trial. Jama. 2017;318(7):637-46.\u003c/li\u003e\n\u003cli\u003eGhassemzadeh H, Mojtabai R, Karamghadiri N, Ebrahimkhani N. Psychometric properties of a Persian‐language version of the Beck Depression Inventory‐Second edition: BDI‐II‐PERSIAN. Depression and anxiety. 2005;21(4):185-92.\u003c/li\u003e\n\u003cli\u003eKaviani H, Mousavi A. Psychometric properties of the Persian version of Beck Anxiety Inventory (BAI). 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Potatoes and risk of chronic disease: a systematic review and dose\u0026ndash;response meta-analysis. European journal of nutrition. 2019;58:2243-51.\u003c/li\u003e\n\u003cli\u003eCahill LE, Pan A, Chiuve SE, Sun Q, Willett WC, Hu FB, et al. Fried-food consumption and risk of type 2 diabetes and coronary artery disease: a prospective study in 2 cohorts of US women and men. The American journal of clinical nutrition. 2014;100(2):667-75.\u003c/li\u003e\n\u003cli\u003eShahidi F. Bailey\u0026apos;s Industrial Oil and Fat Products, Industrial and Nonedible Products from Oils and Fats: John Wiley \u0026amp; Sons; 2005.\u003c/li\u003e\n\u003cli\u003eYang M, Yang Y, Nie S, Xie M, Chen F. Analysis and formation of trans fatty acids in corn oil during the heating process. Journal of the American Oil Chemists\u0026apos; Society. 2012;89(5):859-67.\u003c/li\u003e\n\u003cli\u003eUribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, et al. Advanced glycation end products in foods and a practical guide to their reduction in the diet. Journal of the American Dietetic Association. 2010;110(6):911-6. e12.\u003c/li\u003e\n\u003cli\u003eRajpathak SN, Crandall JP, Wylie-Rosett J, Kabat GC, Rohan TE, Hu FB. The role of iron in type 2 diabetes in humans. Biochimica et Biophysica Acta (BBA)-General Subjects. 2009;1790(7):671-81.\u003c/li\u003e\n\u003cli\u003ePacher P, Beckman JS, Liaudet L. Nitric oxide and peroxynitrite in health and disease. Physiological reviews. 2007;87(1):315-424.\u003c/li\u003e\n\u003cli\u003eMalik VS, Hu FB. Sweeteners and risk of obesity and type 2 diabetes: the role of sugar-sweetened beverages. Current diabetes reports. 2012;12:195-203.\u003c/li\u003e\n\u003cli\u003eLudwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. Jama. 2002;287(18):2414-23.\u003c/li\u003e\n\u003cli\u003eJayedi A, Soltani S, Abdolshahi A, Shab-Bidar S. Healthy and unhealthy dietary patterns and the risk of chronic disease: an umbrella review of meta-analyses of prospective cohort studies. British Journal of Nutrition. 2020;124(11):1133-44.\u003c/li\u003e\n\u003cli\u003eCarlstr\u0026ouml;m M, Larsson SC. Coffee consumption and reduced risk of developing type 2 diabetes: a systematic review with meta-analysis. Nutrition reviews. 2018;76(6):395-417.\u003c/li\u003e\n\u003cli\u003eKnott C, Bell S, Britton A. Alcohol consumption and the risk of type 2 diabetes: a systematic review and dose-response meta-analysis of more than 1.9 million individuals from 38 observational studies. Diabetes care. 2015;38(9):1804-12.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1:Percentage of \u0026nbsp;macronutrients \u0026nbsp;in 1600\u0026nbsp; GDQS \u0026nbsp;diet and 1600 control diet\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"636\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003eMacronutient\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003e1600\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003e1600\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;GDQS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCHO%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e54%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e50%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePr%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e16%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e20%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e\u003cstrong\u003eFat%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e29%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\"\u003e\n \u003cp\u003e30%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 2: Comparison of GDQS scores based on specific food groups in two 1600 GDQS diet and 1600 Control diet\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.064205457463885%\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"39.96789727126806%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e1600 Control\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"39.96789727126806%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e1600 GDQS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u003cstrong\u003eFood Groups\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eConsumed amounts(g/d)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003ePoint values\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eConsumed amounts(g/d)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003ePoint values\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eCitrus fruits\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eDeep orange fruits\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;123\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eOther fruits\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;107\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;107\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eDark green leafy vegetables\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eCruciferous vegetables\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eDeep orange vegetables\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e9-45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.25\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eOther vegetables\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;114\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;114\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003elegumes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eDeep orange tubers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e12-63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eNuts and Seeds\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eWhole Grain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eLiquid oils\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;7.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;7.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eFish and Shellfish\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e14-71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e14-71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003ePoultry and Game meat\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eLow fat dairy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;132\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;132\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eEggs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e6-32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"39.90384615384615%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003eGDQS+ Score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e20.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e30.75\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eHigh fat dairy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eRed meat\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e9-46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e9-46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eProcessed meat\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eRefined grains and baked goods\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eSweets and ice cream\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026gt;37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eSugar-sweetened beverages\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;57\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;57\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eJuice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eWhite roots and tubers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003ePurchased deep fried foods\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e\u0026lt;9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"39.90384615384615%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003eGDQS- Score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.03205128205128%\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.064205457463885%\"\u003e\n \u003cp\u003e\u003cstrong\u003eOverall\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"39.96789727126806%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e31.75\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"39.96789727126806%\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e43.75\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Type 2 diabetes, GDQS-based diet, Nutritional status, Mental health, Lipid profile","lastPublishedDoi":"10.21203/rs.3.rs-4784239/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4784239/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs the most common endocrine disorder, type 2 diabetes is the main cause of more than 4% of deaths worldwide, West Asia and especially Iran is known as one of the regions in the world where the incidence of diabetes has increased significantly in recent years. Failure to control diabetes can cause side effects which reduce the patient's quality of life and increase mental disorders and the mortality rate.So dietary interventions such as a GDQS-based diet may be effective in improving biochemical and blood biomarkers and reducing risk factors in patients with type 2 diabetes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a randomized clinical trial that includes men and women patients with type 2 diabetes. In total, 94 patients with type 2 diabetes were selected based on the entry criteria. Then these patients are randomly assigned to receive the diet based on GDQS (N = 47) or the standard diet of diabetic patients (N = 47) for 12 weeks. The primary outcomes will be the assessment of blood biomarkers (HbA1C, FBS, TG, TC, HDL, LDL) and mental health including (depression, anxiety), sleep quality and quality of life. Anthropometric measurements such as height, weight, waist circumference, body fat percentage, skeletal muscle percentage, body mass index and blood pressure will be considered as secondary outcomes. All outcomes will be measured at the beginning and end (end of 12 weeks) of the study. participants ' adherence will be evaluated using a 3-day food record (2 normal days and one off day) every week.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProspective studies have shown that adherence to healthy eating guidelines, as reflected by higher dietary quality indices, is associated with a lower risk of type 2 diabetes.A common feature among all diets is the consumption of more fruits, vegetables, and whole grains.Thus, a diet that scores high on the GDQS is associated with relatively plant-based diets.Among the foods in the GDQS, high consumption of red and processed meat, refined grains, sugar-sweetened beverages, and potatoes, especially french fries is associated with a higher risk of type 2 diabetes. However, more studies on GDQS-based diets in other populations are needed to confirm its usefulness in various populations to predict non-communicable diseases.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIranian Registry of Clinical Trials (www.irct.ir) IRCT20210427051098N4.Prospectively registered on December 1, 2023.\u003c/p\u003e","manuscriptTitle":"The effect of the Global Diet Quality Score (GDQS)-based diet on glycemic control , mental health and quality of life in patients with type 2 diabetes: a randomized controlled clinical trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-26 11:38:28","doi":"10.21203/rs.3.rs-4784239/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"068ac5a3-8c1a-41db-bba6-e7cbc732d31e","owner":[],"postedDate":"August 26th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-09-23T16:53:33+00:00","versionOfRecord":[],"versionCreatedAt":"2024-08-26 11:38:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4784239","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4784239","identity":"rs-4784239","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}