Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years: Protocol for a Randomized Controlled Trial

Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years: Protocol for a Randomized Controlled 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 Research Article Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years: Protocol for a Randomized Controlled Trial Helia Esmaili, Saeedeh Hosseini Hooshiar, Akram Yazdani, Sadegh Jafarnejad This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3925313/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 An imbalance in appetite and eating behavior, accompanied by heightened food cravings, disrupts the equilibrium between energy intake and energy expenditure, leading to the development of obesity and overweight conditions. There are different dietary strategies to control obesity complications, yet their effects on food behaviors remain an understudied aspect of these interventions. One such intervention gaining increasing attention is intermittent fasting, particularly modified intermittent fasting. Methods This research constitutes a randomized controlled parallel-group trial aimed at comparing the impact of a modified intermittent fasting diet and a daily calorie restriction diet on various factors including appetite, food cravings, eating behavior, and anthropometric indices in women who are classified as either overweight or obese. The study will span a duration of 8 weeks. A total of fifty-four eligible participants will be carefully matched based on their age and BMI, and subsequently allocated to either the "modified intermittent fasting" group or the "daily calorie restriction" group. The primary outcomes include the Visual Analog Scales (VAS) for appetite, the Food Craving Questionnaire (FCQ), the Dutch Eating Behavior Questionnaire (DEBQ), BMI, and Fat-Free Mass (FFM). As secondary outcomes, the study will also explore changes in waist circumference and body fat mass. Discussion This study investigates the effects of an 8-week intermittent fasting intervention compared to a daily calorie restriction approach on appetite, food cravings, and eating behavior. By obtaining this information, we seek to enhance our understanding of the intermittent fasting diet and its potential effects in these domains. Trial registration: Iranian Registry of Clinical Trials IRCT20220522054958N2. Registered on 30 May 2022. https://irct.behdasht.gov.ir/trial/63737 . Intermittent fasting Appetite Food Cravings Eating habits Eating behavior Overweight Obesity. Figures Figure 1 Background Eating behavior encompasses a complex interplay of various processes governing the initiation and termination of meals, as well as factors such as portion size, nutrient composition, meal frequency, and the overall regulation of food intake in relation to the body's energy requirements [ 1 ]. The consumption of food, including appetite regulation, is influenced by multiple factors, such as eating patterns, food density, food variety, and an individual's habitual diet. Furthermore, internal factors, including physiological and psychological variables, can also exert an influence on food intake and appetite [ 1 , 2 ]. In order to effectively control food consumption, the brain plays a crucial role in regulating appetite. Appetite, which encompasses the mental processes governing food-related variables and predicting normal eating behavior, has been extensively studied by researchers over the past fifteen years [ 1 ]. These investigations have aimed to elucidate the underlying mechanisms involved in the establishment of hunger and satiety states within the broader context of appetite regulation [ 1 ]. An imbalance in appetite and eating behavior, accompanied by heightened food cravings, disrupts the equilibrium between energy intake and energy expenditure, leading to the development of obesity and overweight conditions. These conditions carry numerous physical and psychological ramifications [ 3 ]. The global prevalence of obesity and overweight ranges from 15–60% across various geographical regions. Furthermore, in numerous countries, the prevalence of obesity is higher among women compared to men [ 4 ]. There are different dietary strategies to control obesity complications, yet their effects on food behaviors remain an understudied aspect of these interventions. One such intervention gaining increasing attention is intermittent fasting, particularly modified intermittent fasting [ 5 ]. Intermittent fasting is a dietary pattern that involves alternating periods of fasting and eating and modified intermittent fasting is a variation of intermittent fasting that involves modifying the duration or frequency of the fasting periods [ 6 ]. While there is a growing body of research demonstrating the observed effects of intermittent fasting on anthropometric indices such as weight loss, body composition, and metabolic markers, the evidence regarding its influence on food behaviors remains relatively limited [ 7 , 8 ]. Notably, our understanding of the effects of modified intermittent fasting on anthropometric indices and, more critically, food behavior patterns is limited. This knowledge gap emphasizes the urgency of additional research to elucidate the specific impacts of modified intermittent fasting on these aspects. Understanding how intermittent fasting and its variations, such as modified intermittent fasting, influence eating habits, food preferences, and the psychological aspects of food consumption can provide valuable insights for the development of more effective and sustainable approaches to combat obesity and its associated complications. In Kalam et al.'s investigation, the research findings indicate a reduction in body weight and BMI among obese individuals following a low carbohydrate intermittent fasting regimen. Notably, it was observed that the participants' subjective perception of hunger and satiety remained constant throughout the duration of the study [ 1 ]. In a separate research investigation, participants belonging to the intermittent fasting cohort exhibited enhanced compliance with the dietary regimen, accompanied by noticeable enhancements in their appetite regulation [ 9 ]. Furthermore, Shahsavari and colleagues demonstrated a notable disparity, revealing significantly higher levels of emotional eating and uncontrolled eating behaviors among obese individuals when compared to those with normal weight [ 10 ]. Hence, the impact of dietary interventions on these conditions holds significant relevance. A body of contradictory findings is evident in research, as exemplified by the work of Eshghinia et al. In their investigation, participants adhered to a modified intermittent fasting dietary regimen. The outcomes revealed notable enhancements in anthropometric indices compared to baseline measurements, indicating the potential effectiveness of this diet as a viable option for short-term weight reduction [ 11 ]. Conversely, Trepanowski and colleagues, in their research, demonstrated an increase in fat-free mass in participants subjected to both intermittent fasting and daily calorie restriction [ 12 ]. Restricted clinical trials have indicated that fasting regimens possess the capacity to influence appetite and dietary habits. Among the prevalent approaches for mitigating or ameliorating factors associated with obesity is intermittent fasting, entailing regulated food consumption. Several investigations have provided evidence that fasting regimens transcend mere caloric limitations, exerting favorable effects on metabolic processes within the human body [ 13 , 14 ]. The available body of evidence suggests that there is a scarcity of data regarding the increased adherence of obese adults to intermittent fasting diets and their potential for achieving a 3–7% reduction in body weight within short-term intervention periods of 2 to 3 months. This elevated level of compliance may be attributed, at least partially, to advantageous modifications in appetite [ 13 , 15 ]. However, the effects of alternative and modified forms of intermittent fasting on both compliance and the overall effectiveness of the diet remain largely unknown and warrant further investigation. Hence, considering the constraints imposed by clinical trials, the current research endeavor aims to examine the impact of a modified intermittent fasting diet on appetite indicators, food cravings, and eating behavior among women who are classified as obese or overweight. Methods/design Objectives and Study hypothesis Based on the contextual information provided, the primary aim of this research endeavor is to assess the impact of a customized intermittent fasting regimen on various anthropometric parameters, namely BMI, FFM, body fat mass, and waist circumference. Additionally, the study aims to investigate the influence of this dietary intervention on appetite, food cravings, and eating habits among women who are classified as obese or overweight. It is postulated that individuals who are categorized as obese or overweight are likely to exhibit elevated levels of appetite, disordered eating behaviors, and food cravings. It is hypothesized that implementing a modified intermittent fasting diet would be particularly beneficial for this specific population, offering substantial support in addressing these concerns. Design This research constitutes a randomized controlled parallel-group trial aimed at comparing the impact of a modified intermittent fasting diet and a daily calorie restriction diet on various factors including appetite, food cravings, eating behavior, and anthropometric indices in women who are classified as either overweight or obese. The research endeavor will be implemented at Shahid Beheshti Hospital situated in Kashan. The trial will be administered individually under the direction of the principal investigators. The scientific committee will assume the responsibility of supervising the study, particularly during instances of adverse events or when necessary. Kashan University of Medical Sciences will exercise oversight over the comprehensive execution of the trial. The study team will convene on a weekly basis to address and discuss any operational challenges encountered during the study. Given the limited number of patients involved in a single center, the inclusion of a Data Monitoring Committee (DMC) is deemed unnecessary. The selection of participants for this study will be carried out through random sampling from the Health Centers affiliated with Kashan University of Medical Sciences. The study will span a duration of 8 weeks. The participants will be allocated randomly into two groups, namely the daily calorie restriction group and the fasting group, based on specific criteria for inclusion and exclusion. The research protocol for this study has been granted approval by the Ethics Committee of Kashan University of Medical Sciences under the reference number IR.KAUMS.MEDNT.REC.1401.002, and it has also been registered with the Iranian Registry of Clinical Trials under the identifier IRCT20220522054958N2. Prior to the implementation of any study-related procedures, all participants will be required to provide written consent. In this study protocol, we employed the SPIRIT reporting guidelines. [ 16 ]. Study population To conduct this study, we need to determine the sample size based on the waist-to-hip circumference ratio data of a previous study. In that study, the mean and standard deviation of waist-to-hip circumference ratio were 0.96 and 0.05 in the intervention group, and 0.99 and 0.02 in the control group. Taking into account a power of 80% and alpha error of 5%, we will need 27 women in each group. A total of fifty-four individuals will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a simple random sampling technique in accordance with predefined inclusion and exclusion criteria. The eligible participants will be carefully matched based on their age and BMI, and subsequently allocated to either the "modified intermittent fasting" group or the "daily calorie restriction" group. Due to the interventional nature of the study, blinding procedures will not be implemented (Fig. 1). Inclusion and exclusion criteria The inclusion criteria for this study pertain to women aged between 18 and 50 years who fall within the overweight or obese category, with a BMI ranging from 25 to 40. On the other hand, the exclusion criteria include factors such as pregnancy or breastfeeding, the presence of chronic metabolic conditions like diabetes, the existence of cardiovascular disorders such as coronary heart disease and hypertension, gastrointestinal disorders, recent weight loss of at least 1 kg within the past three months, smoking or alcohol abuse, adherence to a specific diet or use of specific medications that may interfere with the trial process, as well as the presence of mental or psychological disorders. Furthermore, the predetermined criteria for terminating assigned interventions for participants in the trial encompass several factors. These factors include deviations in calorie intake that fall below 80% or exceed 110% of the recommended caloric intake, experiencing severe emotional distress throughout the course of the study, engaging in smoking or alcohol consumption, participant unwillingness to continue cooperation or non-adherence to the prescribed diet, presence of chronic conditions such as hypertension, cardiovascular disease, diabetes, or gastrointestinal ailments, and the occurrence of pregnancy or breastfeeding during the study period. Study variables The primary outcomes of this study revolves around examining the variations observed between the interventional groups in terms of alterations from baseline levels in several key variables. These variables include the Visual Analog Scales (VAS) for appetite, the Food Craving Questionnaire (FCQ), the Dutch Eating Behavior Questionnaire (DEBQ), BMI, and Fat-Free Mass (FFM). As secondary outcomes, the study will also explore changes in waist circumference and body fat mass. Interventions The schematic representation of the intervention procedure in this study is presented in Fig. 2 . A total of 54 participants will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a Simple Random Sampling method that adheres to the predefined inclusion and exclusion criteria. Following the baseline assessments, participants will be assigned to either the "modified intermittent fasting" group (intervention) or the "daily calorie restriction" group (control). Throughout the duration of 8 weeks, all participants will be instructed to adhere to their prescribed diet plan, which will be tailored to their respective group assignment and daily energy requirements. The estimation of individual energy requirements will be carried out using the Mifflin equation [ 17 ]. Both intervention groups will adhere to specific dietary compositions, with daily intake comprising 55% carbohydrates, 30% fat, and 15% protein in relation to their energy requirements. The modified intermittent fasting approach will entail alternating cycles of feeding and fasting, following an every-other-day pattern. On fasting days, participants will consume only 25% of the recommended calorie intake, while on feeding days, they will consume 100% of their calculated daily energy requirements. To ensure consistency, all fasting meals will be consumed as lunch between 12 pm and 2 pm, ensuring that each participant undergoes an equal duration of fasting. During fasting days, participants will have permission to consume non-caloric beverages like water, tea, and green tea, as well as coffee without sugar (limited to < 400 mg caffeine daily). Additionally, non-starchy vegetables such as lettuce, green leaf, cucumber, and tomato will be allowed. Adequate hydration will be encouraged by promoting the consumption of ample water. On the days designated for feeding, participants will receive a dietary regimen that aligns with 100% of their individualized energy requirements. This regimen will encompass three primary meals and three snack intervals. Participants will be instructed to consume breakfast within the time frame of 6:00 and 8:00, followed by lunch between 12:00 and 14:00, and dinner between 19:00 and 21:00. Additionally, participants will be encouraged to incorporate three snack periods into their daily routine, with the first snack scheduled for 10:00, the second snack for 16:00, and the final snack for 22:00. Contrarily, the group assigned to daily calorie restriction will adhere to a dietary regimen that corresponds to 63% of their total energy requirement on a daily basis. This regimen will also consist of three main meals and three snack intervals. Similar to the modified intermittent fasting group, participants in the daily calorie restriction group will be instructed to partake in breakfast between 6:00 and 8:00, followed by lunch between 12:00 and 14:00, and dinner between 19:00 and 21:00. Additionally, they will be advised to consume their first snack at 10:00, the second snack at 16:00, and the final snack at 22:00. Both the modified intermittent fasting and daily calorie restriction groups will be required to prepare all of their meals at home. These two groups will strictly adhere to their assigned diets for a duration of 8 weeks. Throughout the study period, participants in both groups will be instructed to maintain their regular physical activity levels. To address any inquiries or concerns, face-to-face and phone consultations will be conducted with a registered dietician. The extent of implementation adherence will be evaluated through the administration of a food record questionnaire every 2 weeks. Participants will be asked to complete this questionnaire for a total of 3 days per week: 2 weekdays and 1 day during the weekend. Adequate adherence will be determined if the calculated total caloric intake of participants falls within the range of 80–110% of the prescribed intake [ 18 ]. Participants will be explicitly instructed to refrain from engaging in any activities that could potentially interfere with the study, such as following a specialized diet, consuming specific supplements or medications. Researchers involved in the study will diligently monitor and evaluate any potential adverse events that directly relate to the study intervention. Continuous monitoring of the patients will be conducted. In the event of any adverse events, such as hypoglycemia or headaches, occurring during the study, they will be promptly reported to the Kashan University of Medical Sciences and the Ethics Committee of Kashan University of Medical Sciences. The managing physician will oversee the appropriate management of these events, and the associated costs will be covered by the trial funding. A comprehensive depiction of the study's design, interventions, as well as the scheduled assessments, can be found in Fig. 1 (participants, interventions, analysis) and Fig. 2 (intervention flow chart). These visual representations provide an organized overview of the study's structure, interventions, and the sequence of evaluations to be conducted. Assessment of study variables Analog Scale VAS: Visual The purpose of employing this questionnaire is to assess the appetite of the participant, encompassing dimensions such as hunger, satiety, satisfaction, and the individual's capacity to consume food. The questionnaire employs a linear scale to capture these variables, with the starting point representing an absence of the attribute under consideration, while the endpoint indicates its maximum extent. The scale is discretized into five distinct states, thereby enabling the quantification of the intensity of an individual's psychological experiences and serving as an indicator of their appetite [ 1 ]. The scale utilized in this study aims to assess the daily appetite of each subject by calculating the average score derived from a set of questions completed prior to the three primary meals of the day. A Food Craving Questionnaire is employed to gauge the intensity of food cravings on a multidimensional scale [ 19 ]. The present questionnaire comprises a total of 30 questions, utilizing a 6-point Likert scale that ranges from "never" to "always" for scoring the responses. FCQ encompasses several distinct factors, including: (i) the intention and planning associated with food consumption (e.g., "Food cravings consistently prompt me to strategize ways to obtain the desired food"), (ii) the anticipation of positive reinforcements derived from eating (e.g., "Eating what I crave brings about a sense of improved well-being"), (iii) the anticipation of relief from negative emotional states through eating (e.g., "Satisfying a craving often alleviates my feelings of depression"), (iv) the potential lack of control over eating when succumbing to food cravings (e.g., "If I indulge in what I crave, I frequently lose control and overeat"), (v) thoughts and preoccupation revolving around food (e.g., "When I experience a craving, my thoughts become consumed by the idea of consuming it"), (vi) the perception of cravings as a physiological state (e.g., "I tend to crave food when my stomach is empty"), (vii) the emotions that may be encountered prior to or during food cravings or eating (e.g., "My emotions frequently trigger a desire to eat"), (viii) environmental cues that may trigger food cravings (e.g., "Being in the presence of someone eating often stimulates my appetite"), and (ix) the experience of guilt resulting from food cravings (e.g., "Indulging in my cravings often leads to feelings of guilt and self-reproach"). Elevated scores on the questionnaire will signify a greater propensity for food cravings in the individual being assessed, while lower scores will indicate a lesser inclination towards such cravings [ 20 ]. Eating behavior In order to assess eating behavior, DEBQ will be administered, consisting of a total of 33 questions. The questionnaire comprises three distinct subscales: emotional eating (relating to the consumption of food as a means of coping with negative emotions), external eating (associated with the consumption of food in response to external cues such as the aroma or visual stimuli), and restrained eating (pertaining to behaviors aimed at restricting food intake). The responses to these questions are measured on a 5-point Likert scale, ranging from 1 (never) to 5 (most of the time). The utilization of norms, Cronbach's alpha coefficients for internal consistency, and Pearson's correlation coefficients to evaluate interrelationships among the scales demonstrate that the subscales exhibit strong internal consistency and factorial validity [ 21 ]. Physical activity scale The physical activity questionnaire employed in this study relies on the concept of metabolic equivalents (METs) to assess participants' physical activity levels. The questionnaire encompasses nine distinct activity levels, ranging from sleep and rest to high-intensity activities, with each level corresponding to a specific range of MET values, where lower MET values indicate lower intensity and higher MET values indicate higher intensity of physical activity [ 22 ]. Anthropometric indices Height measurements will be obtained using a stadiometer with an accuracy of 0.5 cm. The weight of individuals, while wearing light clothing and without shoes, will be measured using a scale with an accuracy of 0.1 kg. Body Mass Index (BMI) will be calculated by dividing the weight in kilograms by the square of the height in meters. The waist-to-hip ratio will be determined by dividing the waist circumference by the hip circumference. Waist circumference will be measured at the midpoint between the iliac crest and the lowest rib, using a non-stretchable measuring tape, while the individual is in a state of normal expiration [ 23 ]. Additional anthropometric measures, including skeletal muscle mass and soft lean mass will be assessed using the Inbody770 model BPM040S12FXX. These anthropometric indices will be measured both at the commencement and conclusion of the study. Baseline and evaluation visits: The primary investigators will establish communication with potential candidates identified through health center consultations, inviting them to participate in the study. Subsequently, an interview will be scheduled with each participant, during which the study's objectives will be thoroughly explained. Participants will be provided with detailed information and, if they express their willingness to participate, they will be invited to sign the informed consent form. In order to monitor and assess participants' compliance with the prescribed diet, food record questionnaires will be administered at biweekly intervals. These questionnaires will be completed for a total of 3 days per week, consisting of two regular weekdays and one non-consecutive day. To provide ongoing support and motivation, researchers will maintain regular communication with participants through phone calls and visits, reinforcing the study protocols and encouraging adherence. Additionally, participants will be subject to regular monitoring via weekly phone interviews. In the event that participants discontinue or deviate from the intervention protocols for any reason, their data will still be included in the analysis using an intention-to-treat approach. Statistical analysis The outcomes will be presented as the mean ± standard deviation for quantitative variables, while frequency distribution will be used for qualitative variables. The normality of the data will be assessed using the Kolmogorov-Smirnov test. A chi-square test will be employed to compare qualitative data between the two groups. Differences in quantitative data between groups will be examined using an independent t-test. In cases where non-parametric assumptions are violated, the Wilcoxon test and paired t-test will be utilized to compare the means of quantitative variables within the group before and after the intervention, for non-parametric and parametric conditions respectively. The Mann-Whitney test and t-test will be employed to compare the means between the two groups, for non-parametric and parametric conditions respectively. To assess the disparity in data changes between the two groups at the conclusion of the study, analysis of covariance (ANCOVA) will be employed. Adjusted p-values will be used for each statistical test to investigate the effects of the intervention, employing the Bonferroni correction to account for multiple outcomes. Multiple regression models and ANCOVA will be utilized to determine if specific variables serve as confounders for the treatment effect and if the treatment effect interacts with particular covariates. No interim analyses are planned to be conducted. Statistical significance will be determined by considering a p-value lower than 0.05. The data analysis will be carried out using the SPSS software. Discussion Given that an imbalance in appetite, food cravings, and eating behavior disorders is a significant contributor to obesity, interventions aimed at weight loss have the potential to influence these factors. Guidelines for the management of obesity commonly advocate for a sustained, moderate energy restriction approach, typically involving a reduction of 20–30% of an individual's energy requirements [ 24 , 25 ]. In recent times, the practice of intermittent fasting has gained significant popularity as a viable approach for achieving weight loss goals, with a substantial portion of individuals opting for this dietary regimen compared to other methods. Furthermore, different adaptations of intermittent fasting have emerged as alternative strategies for effectively managing body weight [ 26 ]. Within these dietary approaches, individuals are not necessarily required to restrict their energy intake on a daily basis [ 27 , 28 ]. The majority of studies involving intermittent fasting have demonstrated varying degrees of weight loss, ranging from 2.5–9.9%, as well as reductions in fat mass [ 29 , 30 ]. However, there have been discrepancies in the findings concerning glucose metabolism, insulin sensitivity, and the regulation of appetite by the hypothalamus [ 31 ]. Despite recent research demonstrating the favorable impacts of the intermittent fasting diet on body composition, its effectiveness in regulating hormonal mechanisms related to energy balance and other specific details remains to be fully elucidated. Furthermore, studies have indicated that practicing dietary restraint can lead to heightened food cravings and potentially contribute to a loss of control over eating behaviors [ 32 ]. Consequently, our research aims to examine the impact of these two dietary approaches on eating behavior and food cravings, as these factors play a significant role in weight regain and obesity. In a recent study conducted by Hooshiar et al., a modified intermittent fasting diet was compared to a daily calorie restriction diet. The findings revealed a greater reduction in weight, BMI, and anthropometric indices among individuals following the intermittent fasting diet. It's worth noting that the study also addressed sleep-related indices [ 33 ] In light of the limited existing research on the impact of these kind of dietary interventions on appetite, food cravings, and eating behavior, we have designed this study to further explore these aspects. The aim of our study is to investigate the effects of an 8-week intermittent fasting intervention compared to a daily calorie restriction approach on appetite, food cravings, and eating behavior. By obtaining this information, we seek to enhance our understanding of the intermittent fasting diet and its potential effects in these domains. Trial status Recruiting for the study will commence in February 2024 and continue until the end of September. The current protocol version is 3 and was last updated on February 1, 2024. Abbreviations ADF Alternate Day Fasting BMI Body Mass Index DEBQ Dutch Eating Behavior Questionnaire FCQ Food Craving Questionnaire FFM Fat-Free Mass IF Intermittent Fasting IMF Intermittent Fasting and Time-Restricted Feeding TRF Time-Restricted Feeding VAS Visual Analog Scales Declarations Funding We acknowledge the financial support provided by Kashan University of Medical Sciences and Health Services for this study. There is no external sponsor for the funder, and there are no agreements in place that restrict researchers' access. Availability of data Upon completion of the study, the final dataset will be made available in an online repository and can be requested if deemed reasonable. Competing interests The authors affirm that they do not have any competing interests associated with the work being submitted for publication. Authors’ contributions Sadegh Jafarnejad (SJ) is the Chief Investigator who came up with the idea for the study and led the proposal and protocol development. Helia Esmaili (HE) and Saeedeh Hosseini Hooshiar (SHH) contributed to the study design and were involved in the proposal development process. Akram Yazdani (AY) was in charge of developing the statistical design for the trial and contributed to the writing of certain sections of the statistical methods and data handling. These contributions are in line with the guidelines for authorship and contributorship, ensuring that each author's role and contribution to the study are clearly defined and acknowledged. Acknowledgements We express our gratitude to all those who have assisted us in preparing this manuscript. 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Seimon RV, Roekenes JA, Zibellini J, Zhu B, Gibson AA, Hills AP, et al. Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials. Mol Cell Endocrinol. 2015;418:153–72. Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, et al. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013;110(8):1534–47. Massey A, Hill AJ. Dieting and food craving. A descriptive, quasi-prospective study. Appetite. 2012;58(3):781–5. Hooshiar SH, Yazdani A, Jafarnejad S. Alternate-day modified fasting diet improves weight loss, subjective sleep quality and daytime dysfunction in women with obesity or overweight: a randomized, controlled trial. Front Nutr. 2023;10:1174293. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3925313","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":294546279,"identity":"3c01bf7f-b2e1-4f41-ad77-6359e9cd35f9","order_by":0,"name":"Helia Esmaili","email":"","orcid":"","institution":"Kashan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Helia","middleName":"","lastName":"Esmaili","suffix":""},{"id":294546280,"identity":"646c3215-bfba-4c24-b5a3-f96292f808cc","order_by":1,"name":"Saeedeh Hosseini Hooshiar","email":"","orcid":"","institution":"Kashan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Saeedeh","middleName":"Hosseini","lastName":"Hooshiar","suffix":""},{"id":294546281,"identity":"c6acd444-85f8-4feb-b8fd-fecfaf45caf8","order_by":2,"name":"Akram Yazdani","email":"","orcid":"","institution":"Kashan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Akram","middleName":"","lastName":"Yazdani","suffix":""},{"id":294546282,"identity":"97768c87-7485-4c19-bd34-21f58ad9d96c","order_by":3,"name":"Sadegh Jafarnejad","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0001-6121-8837","institution":"Kashan University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Sadegh","middleName":"","lastName":"Jafarnejad","suffix":""}],"badges":[],"createdAt":"2024-02-03 21:06:38","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3925313/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3925313/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":55632846,"identity":"bd74ceab-af33-45d5-af89-c4518da8b5a9","added_by":"auto","created_at":"2024-04-30 20:00:31","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":32445,"visible":true,"origin":"","legend":"\u003cp\u003eSchedule of enrolment, interventions, and assessments of the trial.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3925313/v1/4bc07832b0d0d1253396f232.png"},{"id":80528050,"identity":"ab4664a4-d643-482f-b891-83b976f3f0ca","added_by":"auto","created_at":"2025-04-14 10:17:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":606011,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3925313/v1/6394e9af-fc84-4f44-a08c-b2511401575a.pdf"},{"id":55633981,"identity":"15049fe4-5dbb-4a7c-b03c-d56e270ff683","added_by":"auto","created_at":"2024-04-30 20:08:31","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":34935,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-3925313/v1/d676e0a794a8bf0d8bbf4544.docx"}],"financialInterests":"","formattedTitle":"Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years: Protocol for a Randomized Controlled Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eEating behavior encompasses a complex interplay of various processes governing the initiation and termination of meals, as well as factors such as portion size, nutrient composition, meal frequency, and the overall regulation of food intake in relation to the body's energy requirements [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The consumption of food, including appetite regulation, is influenced by multiple factors, such as eating patterns, food density, food variety, and an individual's habitual diet. Furthermore, internal factors, including physiological and psychological variables, can also exert an influence on food intake and appetite [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In order to effectively control food consumption, the brain plays a crucial role in regulating appetite. Appetite, which encompasses the mental processes governing food-related variables and predicting normal eating behavior, has been extensively studied by researchers over the past fifteen years [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. These investigations have aimed to elucidate the underlying mechanisms involved in the establishment of hunger and satiety states within the broader context of appetite regulation [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. An imbalance in appetite and eating behavior, accompanied by heightened food cravings, disrupts the equilibrium between energy intake and energy expenditure, leading to the development of obesity and overweight conditions. These conditions carry numerous physical and psychological ramifications [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The global prevalence of obesity and overweight ranges from 15\u0026ndash;60% across various geographical regions. Furthermore, in numerous countries, the prevalence of obesity is higher among women compared to men [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. There are different dietary strategies to control obesity complications, yet their effects on food behaviors remain an understudied aspect of these interventions. One such intervention gaining increasing attention is intermittent fasting, particularly modified intermittent fasting [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Intermittent fasting is a dietary pattern that involves alternating periods of fasting and eating and modified intermittent fasting is a variation of intermittent fasting that involves modifying the duration or frequency of the fasting periods [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. While there is a growing body of research demonstrating the observed effects of intermittent fasting on anthropometric indices such as weight loss, body composition, and metabolic markers, the evidence regarding its influence on food behaviors remains relatively limited [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Notably, our understanding of the effects of modified intermittent fasting on anthropometric indices and, more critically, food behavior patterns is limited. This knowledge gap emphasizes the urgency of additional research to elucidate the specific impacts of modified intermittent fasting on these aspects. Understanding how intermittent fasting and its variations, such as modified intermittent fasting, influence eating habits, food preferences, and the psychological aspects of food consumption can provide valuable insights for the development of more effective and sustainable approaches to combat obesity and its associated complications. In Kalam et al.'s investigation, the research findings indicate a reduction in body weight and BMI among obese individuals following a low carbohydrate intermittent fasting regimen. Notably, it was observed that the participants' subjective perception of hunger and satiety remained constant throughout the duration of the study [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. In a separate research investigation, participants belonging to the intermittent fasting cohort exhibited enhanced compliance with the dietary regimen, accompanied by noticeable enhancements in their appetite regulation [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Furthermore, Shahsavari and colleagues demonstrated a notable disparity, revealing significantly higher levels of emotional eating and uncontrolled eating behaviors among obese individuals when compared to those with normal weight [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Hence, the impact of dietary interventions on these conditions holds significant relevance. A body of contradictory findings is evident in research, as exemplified by the work of Eshghinia et al. In their investigation, participants adhered to a modified intermittent fasting dietary regimen. The outcomes revealed notable enhancements in anthropometric indices compared to baseline measurements, indicating the potential effectiveness of this diet as a viable option for short-term weight reduction [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Conversely, Trepanowski and colleagues, in their research, demonstrated an increase in fat-free mass in participants subjected to both intermittent fasting and daily calorie restriction [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Restricted clinical trials have indicated that fasting regimens possess the capacity to influence appetite and dietary habits. Among the prevalent approaches for mitigating or ameliorating factors associated with obesity is intermittent fasting, entailing regulated food consumption. Several investigations have provided evidence that fasting regimens transcend mere caloric limitations, exerting favorable effects on metabolic processes within the human body [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe available body of evidence suggests that there is a scarcity of data regarding the increased adherence of obese adults to intermittent fasting diets and their potential for achieving a 3\u0026ndash;7% reduction in body weight within short-term intervention periods of 2 to 3 months. This elevated level of compliance may be attributed, at least partially, to advantageous modifications in appetite [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, the effects of alternative and modified forms of intermittent fasting on both compliance and the overall effectiveness of the diet remain largely unknown and warrant further investigation. Hence, considering the constraints imposed by clinical trials, the current research endeavor aims to examine the impact of a modified intermittent fasting diet on appetite indicators, food cravings, and eating behavior among women who are classified as obese or overweight.\u003c/p\u003e"},{"header":"Methods/design","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eObjectives and Study hypothesis\u003c/h2\u003e \u003cp\u003eBased on the contextual information provided, the primary aim of this research endeavor is to assess the impact of a customized intermittent fasting regimen on various anthropometric parameters, namely BMI, FFM, body fat mass, and waist circumference. Additionally, the study aims to investigate the influence of this dietary intervention on appetite, food cravings, and eating habits among women who are classified as obese or overweight.\u003c/p\u003e \u003cp\u003eIt is postulated that individuals who are categorized as obese or overweight are likely to exhibit elevated levels of appetite, disordered eating behaviors, and food cravings. It is hypothesized that implementing a modified intermittent fasting diet would be particularly beneficial for this specific population, offering substantial support in addressing these concerns.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDesign\u003c/h2\u003e \u003cp\u003eThis research constitutes a randomized controlled parallel-group trial aimed at comparing the impact of a modified intermittent fasting diet and a daily calorie restriction diet on various factors including appetite, food cravings, eating behavior, and anthropometric indices in women who are classified as either overweight or obese. The research endeavor will be implemented at Shahid Beheshti Hospital situated in Kashan. The trial will be administered individually under the direction of the principal investigators. The scientific committee will assume the responsibility of supervising the study, particularly during instances of adverse events or when necessary. Kashan University of Medical Sciences will exercise oversight over the comprehensive execution of the trial. The study team will convene on a weekly basis to address and discuss any operational challenges encountered during the study. Given the limited number of patients involved in a single center, the inclusion of a Data Monitoring Committee (DMC) is deemed unnecessary. The selection of participants for this study will be carried out through random sampling from the Health Centers affiliated with Kashan University of Medical Sciences. The study will span a duration of 8 weeks. The participants will be allocated randomly into two groups, namely the daily calorie restriction group and the fasting group, based on specific criteria for inclusion and exclusion. The research protocol for this study has been granted approval by the Ethics Committee of Kashan University of Medical Sciences under the reference number IR.KAUMS.MEDNT.REC.1401.002, and it has also been registered with the Iranian Registry of Clinical Trials under the identifier IRCT20220522054958N2. Prior to the implementation of any study-related procedures, all participants will be required to provide written consent. In this study protocol, we employed the SPIRIT reporting guidelines. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy population\u003c/h2\u003e \u003cp\u003eTo conduct this study, we need to determine the sample size based on the waist-to-hip circumference ratio data of a previous study. In that study, the mean and standard deviation of waist-to-hip circumference ratio were 0.96 and 0.05 in the intervention group, and 0.99 and 0.02 in the control group. Taking into account a power of 80% and alpha error of 5%, we will need 27 women in each group. A total of fifty-four individuals will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a simple random sampling technique in accordance with predefined inclusion and exclusion criteria. The eligible participants will be carefully matched based on their age and BMI, and subsequently allocated to either the \"modified intermittent fasting\" group or the \"daily calorie restriction\" group. Due to the interventional nature of the study, blinding procedures will not be implemented (Fig.\u0026nbsp;1).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eInclusion and exclusion criteria\u003c/h2\u003e \u003cp\u003eThe inclusion criteria for this study pertain to women aged between 18 and 50 years who fall within the overweight or obese category, with a BMI ranging from 25 to 40. On the other hand, the exclusion criteria include factors such as pregnancy or breastfeeding, the presence of chronic metabolic conditions like diabetes, the existence of cardiovascular disorders such as coronary heart disease and hypertension, gastrointestinal disorders, recent weight loss of at least 1 kg within the past three months, smoking or alcohol abuse, adherence to a specific diet or use of specific medications that may interfere with the trial process, as well as the presence of mental or psychological disorders. Furthermore, the predetermined criteria for terminating assigned interventions for participants in the trial encompass several factors. These factors include deviations in calorie intake that fall below 80% or exceed 110% of the recommended caloric intake, experiencing severe emotional distress throughout the course of the study, engaging in smoking or alcohol consumption, participant unwillingness to continue cooperation or non-adherence to the prescribed diet, presence of chronic conditions such as hypertension, cardiovascular disease, diabetes, or gastrointestinal ailments, and the occurrence of pregnancy or breastfeeding during the study period.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStudy variables\u003c/h2\u003e \u003cp\u003eThe primary outcomes of this study revolves around examining the variations observed between the interventional groups in terms of alterations from baseline levels in several key variables. These variables include the Visual Analog Scales (VAS) for appetite, the Food Craving Questionnaire (FCQ), the Dutch Eating Behavior Questionnaire (DEBQ), BMI, and Fat-Free Mass (FFM). As secondary outcomes, the study will also explore changes in waist circumference and body fat mass.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cp\u003eThe schematic representation of the intervention procedure in this study is presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e2\u003c/span\u003e. A total of 54 participants will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a Simple Random Sampling method that adheres to the predefined inclusion and exclusion criteria. Following the baseline assessments, participants will be assigned to either the \"modified intermittent fasting\" group (intervention) or the \"daily calorie restriction\" group (control). Throughout the duration of 8 weeks, all participants will be instructed to adhere to their prescribed diet plan, which will be tailored to their respective group assignment and daily energy requirements. The estimation of individual energy requirements will be carried out using the Mifflin equation [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Both intervention groups will adhere to specific dietary compositions, with daily intake comprising 55% carbohydrates, 30% fat, and 15% protein in relation to their energy requirements. The modified intermittent fasting approach will entail alternating cycles of feeding and fasting, following an every-other-day pattern. On fasting days, participants will consume only 25% of the recommended calorie intake, while on feeding days, they will consume 100% of their calculated daily energy requirements. To ensure consistency, all fasting meals will be consumed as lunch between 12 pm and 2 pm, ensuring that each participant undergoes an equal duration of fasting. During fasting days, participants will have permission to consume non-caloric beverages like water, tea, and green tea, as well as coffee without sugar (limited to \u0026lt;\u0026thinsp;400 mg caffeine daily). Additionally, non-starchy vegetables such as lettuce, green leaf, cucumber, and tomato will be allowed. Adequate hydration will be encouraged by promoting the consumption of ample water.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eOn the days designated for feeding, participants will receive a dietary regimen that aligns with 100% of their individualized energy requirements. This regimen will encompass three primary meals and three snack intervals. Participants will be instructed to consume breakfast within the time frame of 6:00 and 8:00, followed by lunch between 12:00 and 14:00, and dinner between 19:00 and 21:00. Additionally, participants will be encouraged to incorporate three snack periods into their daily routine, with the first snack scheduled for 10:00, the second snack for 16:00, and the final snack for 22:00. Contrarily, the group assigned to daily calorie restriction will adhere to a dietary regimen that corresponds to 63% of their total energy requirement on a daily basis. This regimen will also consist of three main meals and three snack intervals. Similar to the modified intermittent fasting group, participants in the daily calorie restriction group will be instructed to partake in breakfast between 6:00 and 8:00, followed by lunch between 12:00 and 14:00, and dinner between 19:00 and 21:00. Additionally, they will be advised to consume their first snack at 10:00, the second snack at 16:00, and the final snack at 22:00.\u003c/p\u003e \u003cp\u003eBoth the modified intermittent fasting and daily calorie restriction groups will be required to prepare all of their meals at home. These two groups will strictly adhere to their assigned diets for a duration of 8 weeks. Throughout the study period, participants in both groups will be instructed to maintain their regular physical activity levels. To address any inquiries or concerns, face-to-face and phone consultations will be conducted with a registered dietician. The extent of implementation adherence will be evaluated through the administration of a food record questionnaire every 2 weeks. Participants will be asked to complete this questionnaire for a total of 3 days per week: 2 weekdays and 1 day during the weekend. Adequate adherence will be determined if the calculated total caloric intake of participants falls within the range of 80\u0026ndash;110% of the prescribed intake [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Participants will be explicitly instructed to refrain from engaging in any activities that could potentially interfere with the study, such as following a specialized diet, consuming specific supplements or medications. Researchers involved in the study will diligently monitor and evaluate any potential adverse events that directly relate to the study intervention. Continuous monitoring of the patients will be conducted. In the event of any adverse events, such as hypoglycemia or headaches, occurring during the study, they will be promptly reported to the Kashan University of Medical Sciences and the Ethics Committee of Kashan University of Medical Sciences. The managing physician will oversee the appropriate management of these events, and the associated costs will be covered by the trial funding.\u003c/p\u003e \u003cp\u003eA comprehensive depiction of the study's design, interventions, as well as the scheduled assessments, can be found in Fig.\u0026nbsp;1 (participants, interventions, analysis) and Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e2\u003c/span\u003e (intervention flow chart). These visual representations provide an organized overview of the study's structure, interventions, and the sequence of evaluations to be conducted.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of study variables\u003c/h2\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eAnalog Scale VAS: Visual\u003c/h2\u003e \u003cp\u003eThe purpose of employing this questionnaire is to assess the appetite of the participant, encompassing dimensions such as hunger, satiety, satisfaction, and the individual's capacity to consume food. The questionnaire employs a linear scale to capture these variables, with the starting point representing an absence of the attribute under consideration, while the endpoint indicates its maximum extent. The scale is discretized into five distinct states, thereby enabling the quantification of the intensity of an individual's psychological experiences and serving as an indicator of their appetite [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The scale utilized in this study aims to assess the daily appetite of each subject by calculating the average score derived from a set of questions completed prior to the three primary meals of the day.\u003c/p\u003e \u003cp\u003eA Food Craving Questionnaire is employed to gauge the intensity of food cravings on a multidimensional scale [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The present questionnaire comprises a total of 30 questions, utilizing a 6-point Likert scale that ranges from \"never\" to \"always\" for scoring the responses. FCQ encompasses several distinct factors, including: (i) the intention and planning associated with food consumption (e.g., \"Food cravings consistently prompt me to strategize ways to obtain the desired food\"), (ii) the anticipation of positive reinforcements derived from eating (e.g., \"Eating what I crave brings about a sense of improved well-being\"), (iii) the anticipation of relief from negative emotional states through eating (e.g., \"Satisfying a craving often alleviates my feelings of depression\"), (iv) the potential lack of control over eating when succumbing to food cravings (e.g., \"If I indulge in what I crave, I frequently lose control and overeat\"), (v) thoughts and preoccupation revolving around food (e.g., \"When I experience a craving, my thoughts become consumed by the idea of consuming it\"), (vi) the perception of cravings as a physiological state (e.g., \"I tend to crave food when my stomach is empty\"), (vii) the emotions that may be encountered prior to or during food cravings or eating (e.g., \"My emotions frequently trigger a desire to eat\"), (viii) environmental cues that may trigger food cravings (e.g., \"Being in the presence of someone eating often stimulates my appetite\"), and (ix) the experience of guilt resulting from food cravings (e.g., \"Indulging in my cravings often leads to feelings of guilt and self-reproach\"). Elevated scores on the questionnaire will signify a greater propensity for food cravings in the individual being assessed, while lower scores will indicate a lesser inclination towards such cravings [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eEating behavior\u003c/h2\u003e \u003cp\u003eIn order to assess eating behavior, DEBQ will be administered, consisting of a total of 33 questions. The questionnaire comprises three distinct subscales: emotional eating (relating to the consumption of food as a means of coping with negative emotions), external eating (associated with the consumption of food in response to external cues such as the aroma or visual stimuli), and restrained eating (pertaining to behaviors aimed at restricting food intake). The responses to these questions are measured on a 5-point Likert scale, ranging from 1 (never) to 5 (most of the time). The utilization of norms, Cronbach's alpha coefficients for internal consistency, and Pearson's correlation coefficients to evaluate interrelationships among the scales demonstrate that the subscales exhibit strong internal consistency and factorial validity [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePhysical activity scale\u003c/h2\u003e \u003cp\u003eThe physical activity questionnaire employed in this study relies on the concept of metabolic equivalents (METs) to assess participants' physical activity levels. The questionnaire encompasses nine distinct activity levels, ranging from sleep and rest to high-intensity activities, with each level corresponding to a specific range of MET values, where lower MET values indicate lower intensity and higher MET values indicate higher intensity of physical activity [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eAnthropometric indices\u003c/h2\u003e \u003cp\u003eHeight measurements will be obtained using a stadiometer with an accuracy of 0.5 cm. The weight of individuals, while wearing light clothing and without shoes, will be measured using a scale with an accuracy of 0.1 kg. Body Mass Index (BMI) will be calculated by dividing the weight in kilograms by the square of the height in meters. The waist-to-hip ratio will be determined by dividing the waist circumference by the hip circumference. Waist circumference will be measured at the midpoint between the iliac crest and the lowest rib, using a non-stretchable measuring tape, while the individual is in a state of normal expiration [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Additional anthropometric measures, including skeletal muscle mass and soft lean mass will be assessed using the Inbody770 model BPM040S12FXX. These anthropometric indices will be measured both at the commencement and conclusion of the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eBaseline and evaluation visits:\u003c/h2\u003e \u003cp\u003eThe primary investigators will establish communication with potential candidates identified through health center consultations, inviting them to participate in the study. Subsequently, an interview will be scheduled with each participant, during which the study's objectives will be thoroughly explained. Participants will be provided with detailed information and, if they express their willingness to participate, they will be invited to sign the informed consent form. In order to monitor and assess participants' compliance with the prescribed diet, food record questionnaires will be administered at biweekly intervals. These questionnaires will be completed for a total of 3 days per week, consisting of two regular weekdays and one non-consecutive day. To provide ongoing support and motivation, researchers will maintain regular communication with participants through phone calls and visits, reinforcing the study protocols and encouraging adherence. Additionally, participants will be subject to regular monitoring via weekly phone interviews. In the event that participants discontinue or deviate from the intervention protocols for any reason, their data will still be included in the analysis using an intention-to-treat approach.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe outcomes will be presented as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation for quantitative variables, while frequency distribution will be used for qualitative variables. The normality of the data will be assessed using the Kolmogorov-Smirnov test. A chi-square test will be employed to compare qualitative data between the two groups. Differences in quantitative data between groups will be examined using an independent t-test. In cases where non-parametric assumptions are violated, the Wilcoxon test and paired t-test will be utilized to compare the means of quantitative variables within the group before and after the intervention, for non-parametric and parametric conditions respectively. The Mann-Whitney test and t-test will be employed to compare the means between the two groups, for non-parametric and parametric conditions respectively.\u003c/p\u003e \u003cp\u003eTo assess the disparity in data changes between the two groups at the conclusion of the study, analysis of covariance (ANCOVA) will be employed. Adjusted p-values will be used for each statistical test to investigate the effects of the intervention, employing the Bonferroni correction to account for multiple outcomes. Multiple regression models and ANCOVA will be utilized to determine if specific variables serve as confounders for the treatment effect and if the treatment effect interacts with particular covariates. No interim analyses are planned to be conducted. Statistical significance will be determined by considering a p-value lower than 0.05. The data analysis will be carried out using the SPSS software.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eGiven that an imbalance in appetite, food cravings, and eating behavior disorders is a significant contributor to obesity, interventions aimed at weight loss have the potential to influence these factors. Guidelines for the management of obesity commonly advocate for a sustained, moderate energy restriction approach, typically involving a reduction of 20\u0026ndash;30% of an individual's energy requirements [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. In recent times, the practice of intermittent fasting has gained significant popularity as a viable approach for achieving weight loss goals, with a substantial portion of individuals opting for this dietary regimen compared to other methods. Furthermore, different adaptations of intermittent fasting have emerged as alternative strategies for effectively managing body weight [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Within these dietary approaches, individuals are not necessarily required to restrict their energy intake on a daily basis [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. The majority of studies involving intermittent fasting have demonstrated varying degrees of weight loss, ranging from 2.5\u0026ndash;9.9%, as well as reductions in fat mass [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. However, there have been discrepancies in the findings concerning glucose metabolism, insulin sensitivity, and the regulation of appetite by the hypothalamus [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite recent research demonstrating the favorable impacts of the intermittent fasting diet on body composition, its effectiveness in regulating hormonal mechanisms related to energy balance and other specific details remains to be fully elucidated. Furthermore, studies have indicated that practicing dietary restraint can lead to heightened food cravings and potentially contribute to a loss of control over eating behaviors [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Consequently, our research aims to examine the impact of these two dietary approaches on eating behavior and food cravings, as these factors play a significant role in weight regain and obesity. In a recent study conducted by Hooshiar et al., a modified intermittent fasting diet was compared to a daily calorie restriction diet. The findings revealed a greater reduction in weight, BMI, and anthropometric indices among individuals following the intermittent fasting diet. It's worth noting that the study also addressed sleep-related indices [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] In light of the limited existing research on the impact of these kind of dietary interventions on appetite, food cravings, and eating behavior, we have designed this study to further explore these aspects. The aim of our study is to investigate the effects of an 8-week intermittent fasting intervention compared to a daily calorie restriction approach on appetite, food cravings, and eating behavior. By obtaining this information, we seek to enhance our understanding of the intermittent fasting diet and its potential effects in these domains.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eRecruiting for the study will commence in February 2024 and continue until the end of September. The current protocol version is 3 and was last updated on February 1, 2024.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eADF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAlternate Day Fasting\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\"\u003eDEBQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDutch Eating Behavior Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFCQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFood Craving Questionnaire\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\"\u003eIF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIntermittent Fasting\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIMF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIntermittent Fasting and Time-Restricted Feeding\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTRF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTime-Restricted Feeding\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVAS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVisual Analog Scales\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe acknowledge the financial support provided by Kashan University of Medical Sciences and Health Services for this study. There is no external sponsor for the funder, and there are no agreements in place that restrict researchers\u0026apos; access.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUpon completion of the study, the final dataset will be made available in an online repository and can be requested if deemed reasonable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors affirm that they do not have any competing interests associated with the work being submitted for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSadegh Jafarnejad (SJ) is the Chief Investigator who came up with the idea for the study and led the proposal and protocol development. Helia Esmaili (HE) and Saeedeh Hosseini Hooshiar (SHH) contributed to the study design and were involved in the proposal development process. Akram Yazdani (AY) was in charge of developing the statistical design for the trial and contributed to the writing of certain sections of the statistical methods and data handling. These contributions are in line with the guidelines for authorship and contributorship, ensuring that each author\u0026apos;s role and contribution to the study are clearly defined and acknowledged.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe express our gratitude to all those who have assisted us in preparing this manuscript. We appreciate the valuable contributions of everyone who has helped us in this endeavor.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKalam F, Gabel K, Cienfuegos S, Wiseman E, Ezpeleta M, Pavlou V, et al. Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet. Clin Nutr ESPEN. 2021;41:417\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePolidori D, Sanghvi A, Seeley RJ, Hall KD. How strongly does appetite counter weight loss? Quantification of the feedback control of human energy intake. Obesity. 2016;24(11):2289\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTaheri M, Irandoust K. The exercise-induced weight loss improves self-reported quality of sleep in obese elderly women with sleep disorders. Sleep Hypn. 2018;20(1):54\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBray GA. Obesity-a disease of nutrient or energy balance? Nutr Rev. 1987;45(4):33\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBurrows T, Warren J, Baur L, Collins C. Impact of a child obesity intervention on dietary intake and behaviors. Int J Obes. 2008;32(10):1481\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJanaswamy R, Yelne P. A Narrative Review on Intermittent Fasting as an Approachable Measure for Weight Reduction and Obesity Management. Cureus. 2022;14(10).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWelton S, Minty R, O\u0026rsquo;Driscoll T, Willms H, Poirier D, Madden S, et al. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020;66(2):117\u0026ndash;25.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePatterson RE, Sears DD. Metabolic effects of intermittent fasting. Annu Rev Nutr. 2017;37:371\u0026ndash;93.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKroeger CM, Trepanowski JF, Klempel MC, Barnosky A, Bhutani S, Gabel K, et al. Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. Nutr Health. 2018;24(1):5\u0026ndash;10.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShahsavari M, Fathi Ashtiani A, Rasoolzadeh Tabatabae K. Body mass index: comparison of emotion regulation and eating behavior. Yafteh. 2016;18(3):104\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEshghinia S, Mohammadzadeh F. The effects of modified alternate-day fasting diet on weight loss and CAD risk factors in overweight and obese women. J Diabetes Metabolic Disorders. 2013;12:1\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTrepanowski JF, Kroeger CM, Barnosky A, Klempel M, Bhutani S, Hoddy KK, et al. Effects of alternate-day fasting or daily calorie restriction on body composition, fat distribution, and circulating adipokines: secondary analysis of a randomized controlled trial. Clin Nutr. 2018;37(6):1871\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHoddy KK, Marlatt KL, \u0026Ccedil;etinkaya H, Ravussin E. Intermittent Fasting and Metabolic Health: From Religious Fast to Time-Restricted Feeding. Obes (Silver Spring Md). 2020;28(Suppl 1Suppl 1):29\u0026ndash;s37.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarris L, Hamilton S, Azevedo LB, Olajide J, De Br\u0026uacute;n C, Waller G, et al. Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis. JBI Evid Synthesis. 2018;16(2):507\u0026ndash;47.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Varady KA. Alternate day fasting and endurance exercise combine to reduce body weight and favorably alter plasma lipids in obese humans. Obesity. 2013;21(7):1370\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990;51(2):241\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDel Razo-Olvera FM, Martin-Vences AJ, Brito-C\u0026oacute;rdova GX, El\u0026iacute;as-L\u0026oacute;pez D, Landa-Anell MV, Melgarejo-Hern\u0026aacute;ndez MA, et al. Primary barriers of adherence to a structured nutritional intervention in patients with dyslipidemia. Nutrients. 2021;13(6):1744.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKhanjari C, Khajevand A. The effectiveness of Schema Therapy on temperament and character dimensions, food craving among obese women with type 2 diabetes. Adv Cogn Sci. 2020;22(3):14\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCepeda-Benito A, Gleaves DH, Fern\u0026aacute;ndez MC, Vila J, Williams TL, Reynoso J. The development and validation of Spanish versions of the State and Trait Food Cravings Questionnaires. Behav Res Ther. 2000;38(11):1125\u0026ndash;38.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCebolla A, Barrada J, Van Strien T, Oliver E, Ba\u0026ntilde;os R. Validation of the Dutch Eating Behavior Questionnaire (DEBQ) in a sample of Spanish women. Appetite. 2014;73:58\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAadahl M, J\u0026oslash;rgensen T. Validation of a new self-report instrument for measuring physical activity. Med Sci Sports Exerc. 2003;35(7):1196\u0026ndash;202.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAnuurad E, Shiwaku K, Nogi A, Kitajima K, Enkhmaa B, Shimono K, et al. The new BMI criteria for asians by the regional office for the western pacific region of WHO are suitable for screening of overweight to prevent metabolic syndrome in elder Japanese workers. J Occup Health. 2003;45(6):335\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeighton K, Batterham RL, Stensel DJ. Appetite and gut peptide responses to exercise and calorie restriction. The effect of modest energy deficits. Appetite. 2014;81:52\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLean M, Malkova D. Altered gut and adipose tissue hormones in overweight and obese individuals: cause or consequence? Int J Obes. 2016;40(4):622\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarvie M, Howell A. Potential benefits and harms of intermittent energy restriction and intermittent fasting amongst obese, overweight and normal weight subjects\u0026mdash;a narrative review of human and animal evidence. Behav Sci. 2017;7(1):4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAsh S, Reeves M, Yeo S, Morrison G, Carey D, Capra S. Effect of intensive dietetic interventions on weight and glycaemic control in overweight men with Type II diabetes: a randomised trial. Int J Obes. 2003;27(7):797\u0026ndash;802.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSadeghian M, Hosseini SA, Zare Javid A, Ahmadi Angali K, Mashkournia A. Effect of Fasting-Mimicking Diet or Continuous Energy Restriction on Weight Loss, Body Composition, and Appetite-Regulating Hormones Among Metabolically Healthy Women with Obesity: a Randomized Controlled, Parallel Trial. Obes Surg. 2021;31(5):2030\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eByrne NM, Sainsbury A, King NA, Hills A, Wood R. Intermittent energy restriction improves weight loss efficiency in obese men: the MATADOR study. Int J Obes. 2018;42(2):129\u0026ndash;38.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSeimon RV, Roekenes JA, Zibellini J, Zhu B, Gibson AA, Hills AP, et al. Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials. Mol Cell Endocrinol. 2015;418:153\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, et al. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013;110(8):1534\u0026ndash;47.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMassey A, Hill AJ. Dieting and food craving. A descriptive, quasi-prospective study. Appetite. 2012;58(3):781\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHooshiar SH, Yazdani A, Jafarnejad S. Alternate-day modified fasting diet improves weight loss, subjective sleep quality and daytime dysfunction in women with obesity or overweight: a randomized, controlled trial. Front Nutr. 2023;10:1174293.\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":true,"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":"Intermittent fasting, Appetite, Food Cravings, Eating habits, Eating behavior, Overweight, Obesity.","lastPublishedDoi":"10.21203/rs.3.rs-3925313/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3925313/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAn imbalance in appetite and eating behavior, accompanied by heightened food cravings, disrupts the equilibrium between energy intake and energy expenditure, leading to the development of obesity and overweight conditions. There are different dietary strategies to control obesity complications, yet their effects on food behaviors remain an understudied aspect of these interventions. One such intervention gaining increasing attention is intermittent fasting, particularly modified intermittent fasting.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis research constitutes a randomized controlled parallel-group trial aimed at comparing the impact of a modified intermittent fasting diet and a daily calorie restriction diet on various factors including appetite, food cravings, eating behavior, and anthropometric indices in women who are classified as either overweight or obese. The study will span a duration of 8 weeks. A total of fifty-four eligible participants will be carefully matched based on their age and BMI, and subsequently allocated to either the \"modified intermittent fasting\" group or the \"daily calorie restriction\" group. The primary outcomes include the Visual Analog Scales (VAS) for appetite, the Food Craving Questionnaire (FCQ), the Dutch Eating Behavior Questionnaire (DEBQ), BMI, and Fat-Free Mass (FFM). As secondary outcomes, the study will also explore changes in waist circumference and body fat mass.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThis study investigates the effects of an 8-week intermittent fasting intervention compared to a daily calorie restriction approach on appetite, food cravings, and eating behavior. By obtaining this information, we seek to enhance our understanding of the intermittent fasting diet and its potential effects in these domains.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eIranian Registry of Clinical Trials IRCT20220522054958N2. Registered on 30 May 2022. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://irct.behdasht.gov.ir/trial/63737\u003c/span\u003e\u003cspan address=\"https://irct.behdasht.gov.ir/trial/63737\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/p\u003e","manuscriptTitle":"Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years: Protocol for a Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-30 20:00:26","doi":"10.21203/rs.3.rs-3925313/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":"099df3e5-8de2-4c42-a038-03fdf626556c","owner":[],"postedDate":"April 30th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-14T10:09:05+00:00","versionOfRecord":[],"versionCreatedAt":"2024-04-30 20:00:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3925313","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3925313","identity":"rs-3925313","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}