Investigating the impact of Optimized Nutri-Dense Meals on diet-related quality of life after gastrectomy for gastric cancer

Investigating the impact of Optimized Nutri-Dense Meals on diet-related quality of life after gastrectomy for gastric cancer | 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 Investigating the impact of Optimized Nutri-Dense Meals on diet-related quality of life after gastrectomy for gastric cancer Masayuki Shinkai, Motohiro Imano, Shintaro Fujii, Jun Iimura, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8216854/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Objective Gastrectomy is an essential component of gastric cancer treatment. However, it is often accompanied by appetite loss, reduced food intake, malabsorption, and body weight loss, which inevitably contribute to a decline in diet-related quality of life (QOL). In this study, we investigated the effects of Optimized Nutri-Dense Meals (Opti Meal) on patients following gastrectomy. Opti Meal is a newly developed balanced diet containing 33 essential nutrients. Methods Thirty-nine patients who had undergone gastrectomy for gastric cancer consumed one serving of Opti Meal every other day for 4 weeks. Changes in diet-related QOL scores, body weight, blood test parameters, and the safety of Opti Meal were evaluated. Results The 39 participants comprised 20 patients who underwent total gastrectomy, 17 distal gastrectomy, 1 proximal gastrectomy, and 1 pylorus-preserving gastrectomy. No changes in body weight or nutrition-related laboratory data were observed after Opti Meal consumption. However, diet-related QOL scores—including enjoyment of meals, dietary satisfaction, dietary environment, vitality, and mental health—increased significantly after 4 weeks of Opti Meal intake. By surgical procedure, patients who underwent total gastrectomy showed a significantly greater improvement in “enjoyment of meals” compared with those in other surgical groups. No safety issues were identified with Opti Meal consumption. Conclusion Dietary intervention with Opti Meal may be beneficial for improving diet-related QOL after gastrectomy for gastric cancer. diet-related quality of life Opti Meal gastric cancer gastrectomy Figures Figure 1 Introduction Gastric cancer (GC) is the fifth most common cancer worldwide and the fourth leading cause of cancer-related death [ 1 ]. Gastrectomy remains a highly effective treatment for GC; however, patients who undergo this procedure often experience reduced appetite and food intake due to microgastric symptoms and decreased ghrelin secretion, leading to body weight loss (BWL) [ 2 – 6 ]. Post-gastrectomy BWL has been linked to impaired quality of life (QOL), poor adherence to adjuvant chemotherapy, and unfavorable prognosis [ 7 ]. Consequently, several studies have investigated the potential of oral nutritional supplements (ONS) to prevent BWL in gastrectomy patients, yet the effectiveness of ONS in mitigating weight loss remains inconclusive [ 8 – 11 ]. Postoperative GC patients experience not only post-gastrectomy syndromes such as esophageal reflux, abdominal pain, lethargy, diarrhea, constipation, and dumping syndrome [ 12 ], but also a marked decline in QOL—particularly in aspects related to eating, such as hunger, early satiety, and fewer opportunities to enjoy food. We believe that improving the diet-related QOL of post-gastrectomy patients is an important clinical goal. Recently, “Optimized Nutri-Dense Meals” (Opti Meal) have been developed, designed to balance major nutrients according to individual factors such as age, sex, and lifestyle. This dietary intervention is based on 33 nutrients defined in Japan’s Dietary Reference Intakes [ 13 ]. Several studies have reported the benefits of Opti Meal interventions for individuals with elevated HbA1c levels and for frail patients [ 14 , 15 ]. Building on these findings, we hypothesized that dietary intervention using Opti Meal may also be beneficial for post-gastrectomy patients. In this study, we examined the effects of Opti Meal on diet-related QOL, body weight, and nutrition-related parameters in postoperative GC patients. Material and methods Study design This 4-week, open-label intervention study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Ethics Committee of the Kindai University Faculty of Medicine, following the ethical guidelines for research involving humans established by the Ministry of Health, Labour and Welfare of Japan. The trial was registered in the UMIN Clinical Trials Registry (UMIN000051309). Informed consent was obtained from all participants, allowing publication of the study results under the condition that personal information would remain confidential. Study population The eligibility criteria for this study were as follows: age of 18 years or older, history of gastrectomy for the treatment of GC, attendance at outpatient consultations approximately once per month, no evidence of GC recurrence, ability to consume an Opti Meal without difficulty, and provision of free and voluntary written consent after receiving full information about study participation. The exclusion criteria were as follows: irregular eating habits (e.g., skipping breakfast, lunch, or dinner); particularly selective or picky eating habits; presence of, or risk for, food allergies; and determination by the principal investigator that participation was unsuitable. Interventions The participants consumed an Opti Meal once every 2 days, choosing to take it as breakfast, lunch, dinner, or a snack over a 4-week period. Personal preferences were considered, and menu selections were discussed during the informed consent process. All test meals were delivered once every 2 weeks as frozen meal sets to be consumed at home. Each meal was designed to include 33 nutrients, as described in a previous study [ 13 ]. There were no restrictions on snacks or alcohol consumption. Participants were asked to record the following information in a daily diary: meal details, amount of alcohol consumed, number of medications or health foods taken, level of physical activity, lifestyle changes, prohibited actions, and any symptoms observed. Outcomes The primary outcomes were changes in both quantitative and qualitative satisfaction with food, as well as overall subjective satisfaction. The secondary outcomes included changes in nutrition-related and other blood laboratory parameters, immunonutritional indicators, body weight, and the safety of Opti Meal consumption. Procedures Diet-related QOL scale Diet-related QOL was assessed using the tool developed by Suzukamo et al. [ 16 , 17 ]. This scale was designed to evaluate both quantitative and qualitative satisfaction with diet, as well as the impact of dietary changes on social life functions [ 16 , 17 ]. In this study, we selected three items (Questions 1, 2, and 8) from the eight items of the original questionnaire developed by Suzukamo et al. [ 17 ] to assess the effect of Opti Meal on the diet-related QOL of GC patients after gastrectomy. The diet-related QOL scale comprises seven subscales: (1) Dietary satisfaction, (2) Enjoyment of meals, (3) Dietary environment, (4) Location change, (5) Overall meal feeling, (6) Vitality, and (7) Mental health. Subscale structure Dietary satisfaction consists of six items (Questions 1, 2, 7, 9, 15, and 16 in Question 1). Enjoyment of meals consists of five items (Questions 3, 4, 8, 13, and 14 in Question 1). Dietary environment consists of four items (Questions 5, 6, 11, and 12 in Question 1). Location change consists of one item (Question 10 in Question 1). Overall meal feeling corresponds to Question 2. Vitality consists of four items (Questions 1, 5, 7, and 9 in Question 8). Mental health consists of five items (Questions 2, 3, 4, 6, and 8 in Question 8) (Fig. 1 ). Subscales (1)–(4) were designed to assess QOL directly related to dietary habits, while subscales (5)–(7) were adapted from the Japanese version of the SF-36 [ 18 , 19 ] as a comprehensive measure of health-related QOL reflecting restrictions in daily life functions. Each item was rated on a 5-point Likert scale. Subscale scores were calculated by summing item scores and converting them to a 0–100 scale, with higher scores indicating better QOL. In addition, the SF-36 Japanese version—widely used as a comprehensive tool for evaluating health-related QOL—was also administered, with higher scores again reflecting better QOL. Laboratory tests Blood samples were collected to measure total protein, albumin, cholinesterase, total cholesterol, triglycerides, and C-reactive protein. Immunonutritional indicator The prognostic nutritional index (PNI) was calculated. Physical parameter Body weight was measured. Safety Safety was assessed based on the occurrence of adverse events and the presence of abnormal test results. Statistical analysis Because this was an exploratory study, no formal sample size calculation was performed; the target number of participants was set at 40 based on feasibility. All measurements are presented as mean ± standard deviation. Within-group comparisons were conducted using the Wilcoxon signed-rank test for diet-related QOL scales and paired t-tests for other continuous variables, comparing values at baseline and at 4 weeks post-intervention. Between-group comparisons were performed using the Mann–Whitney U test for diet-related QOL scales and unpaired t-tests for other variables, focusing on the changes from baseline to 4 weeks post-intervention. All statistical tests were two-sided, with a significance level of 5%. Analyses were performed using BellCurve for Excel, version 4.06 (Social Survey Research Information Co., Ltd., Tokyo, Japan). Results Patient characteristics Between May 2023 and October 2023, 41 patients were recruited for this study. Two patients were excluded because they consumed less than 40% of an Opti Meal, leaving 39 patients for analysis. The baseline characteristics of these patients are shown in Table 1. Their median age was 74 years (range, 42–86). Among the 39 patients, 20 had undergone total gastrectomy, 17 distal gastrectomy, 1 proximal gastrectomy, and 1 pylorus-preserving gastrectomy. The mean time from surgery to study intervention was 3.97 years (range, 1.36–30.38). Evaluation of various parameters Blood tests conducted after 4 weeks of Opti Meal consumption showed no significant changes in the red blood cell count, hematocrit, white blood cell (WBC) count, WBC fraction, or platelet count. However, a decrease in hemoglobin (Hb) levels was observed after consumption of the Opti Meal (p = 0.0111). Regarding nutrition-related laboratory data, there were no significant changes in total protein, albumin, cholinesterase, total cholesterol, or triglyceride levels after 4 weeks of Opti Meal consumption. The PNI was used as an immunonutritional assessment, and no increase in PNI values was observed after 4 weeks. Body weight was evaluated as a physical parameter, but no weight gain was observed following 4 weeks of Opti Meal intake (Table 2). Changes in diet-related QOL with consumption of the Opti Meal The diet-related QOL before and after consumption of the Opti Meal is presented in Table 3. The QOL score for “Dietary satisfaction” increased from 51.24 ± 19.37 to 72.12 ± 14.63 after 4 weeks of Opti Meal consumption (p = 0.0001). The score for “Enjoyment of meals” rose from 49.36 ± 19.20 to 60.90 ± 17.39 (p = 0.0012). The score for “Dietary environment” increased from 69.23 ± 17.93 to 77.99 ± 14.72 (p = 0.0034). By contrast, no significant changes were observed in the QOL scores for “Location change” or “Overall meal feeling” after 4 weeks of Opti Meal consumption. However, improvements were noted in the scores for “Vitality” and “Mental health” following the 4-week intervention. Diet-related QOL assessment by surgical procedure In the total gastrectomy (TG) group, the QOL score for “Dietary satisfaction” increased from 47.42 ± 19.14 to 71.46 ± 15.07 after 4 weeks of Opti Meal consumption (p = 0.0001). In the distal gastrectomy (DG) group, the score increased from 57.11 ± 19.25 to 73.28 ± 14.88 after 4 weeks (p = 0.0013). However, no significant difference in “Dietary satisfaction” was observed between the TG and DG groups based on surgical procedure (p = 0.1018). In the TG group, the QOL score for “Enjoyment of meals” increased from 47.00 ± 21.79 to 66.25 ± 13.75 after 4 weeks (p = 0.0029). By contrast, in the DG group, the score remained largely unchanged, increasing from 52.06 ± 17.24 to 55.59 ± 20.45 after 4 weeks (p = 0.4096). Therefore, in terms of “Enjoyment of meals,” the TG group showed a significant improvement in meal-related QOL compared with the DG group (p = 0.0431). In the TG group, the QOL score for “Dietary environment” increased from 67.19 ± 19.33 to 77.08 ± 16.94 after 4 weeks (p = 0.0199). In the DG group, the score remained largely unchanged, rising slightly from 71.69 ± 16.99 at baseline to 78.68 ± 12.31 after 4 weeks (p = 0.1776). No significant difference in “Dietary environment” was observed between the TG and DG groups (p = 0.5293). For “Location change” and “Overall meal feeling,” neither the TG nor the DG group showed improvement in QOL after 4 weeks of Opti Meal consumption, and no differences were found between the groups. Regarding “Vitality” and “Mental health,” improvements in QOL were observed in both the TG and DG groups after 4 weeks of Opti Meal intake, but no significant differences between the two groups were detected according to surgical procedure (Table 4). Evaluation of safety No symptoms such as moodiness, nausea, diarrhea, or abdominal pain were observed that could be attributed to the consumption of the Opti Meal. Overall, no significant safety concerns were identified with the Opti Meal. Discussion Following gastrectomy, patients experience not only loss of appetite and weight loss but also a variety of post-gastrectomy symptoms resulting from reduced gastric storage capacity, decreased digestive function, and diminished ghrelin secretion [ 2 , 3 , 6 ]. These factors collectively have a negative impact on patients’ QOL after surgery. We believe that improving diet-related QOL is a particularly important aspect of the post-gastrectomy lifestyle for GC patients. Therefore, this study focused on diet-related QOL as a means to address this issue. In this study, we examined the effects of the Opti Meal on patients with GC who had undergone gastrectomy. The Opti Meal incorporates 33 essential nutrients and has been reported to help improve HbA1c levels in patients with diabetes and to aid in the prevention of frailty [ 14 , 15 ]. We evaluated the blood data of post-gastrectomy GC patients after 4 weeks of Opti Meal consumption and found no changes in WBC, red blood cell, or platelet counts. However, a decrease in Hb levels was observed following the intervention. Because the Opti Meal provides the recommended daily amount of iron for Japanese individuals, the cause of this decline in Hb levels remains unclear but may have been influenced by seasonal factors. The intervention period for this study spanned from May to October, with many participants enrolled between July and September—the peak of summer in Japan. Previous reports have shown that Hb concentration is inversely correlated with air temperature [ 20 ]. In addition, sweating is known to contribute to iron deficiency anemia [ 21 ]. Therefore, increased perspiration due to the extreme summer heat may have been a contributing factor to the observed decrease in Hb levels. The 4-week Opti Meal intervention did not produce any changes in nutrition-related indicators such as albumin or cholesterol levels. Similarly, previous studies investigating ONS intake (300–400 kcal/day) in post-gastrectomy patients have also reported no significant improvements in nutritional parameters [ 22 , 23 ]. Although the Opti Meal contains 33 nutrients and provides 367–572 kcal per meal, we believe that a 4-week intervention period may be insufficient to produce measurable improvements in nutritional status. In this study, we evaluated the immunonutritional effects of the Opti Meal intervention using the PNI. The PNI, calculated from serum albumin concentration and peripheral blood lymphocyte count, serves as an indicator of the nutritional and immunological status of patients with various cancers [ 24 ]. The preoperative PNI has been identified as a predictive marker for both long-term prognosis and short-term outcomes in patients with GC [ 25 , 26 ]. Moreover, recent studies have reported that improved postoperative PNI levels in patients with gastrointestinal cancer are associated with a better prognosis [ 27 , 28 ]. Therefore, we consider postoperative improvement in the PNI to be an important goal for patients with GC. In this study, however, no changes were observed in albumin levels or lymphocyte counts after 4 weeks of Opti Meal consumption, and consequently, no improvement in PNI values was detected. Further investigation will be needed to determine whether extending the intervention period may lead to improvements in the PNI. Additionally, the 4-week Opti Meal intervention did not result in any changes in body weight. Omori et al. [ 23 ] reported that patients who received ONS supplementation for 3 months after gastrectomy experienced less weight loss than those in the control group. Therefore, the weight-preserving effect of the Opti Meal intervention may have been too modest to produce measurable results within a 4-week period. Another possible explanation is that weight loss after gastrectomy is time-dependent, being most pronounced during the first 3 months postoperatively [ 29 ]. Based on this, Omori et al. [ 23 ] initiated ONS supplementation within 3 days of patients resuming normal oral intake after surgery. By contrast, all participants in our study had undergone surgery more than 1 year prior to the intervention, suggesting that the Opti Meal dietary intervention may have had little effect on body weight in this population. In this study, we used the diet-related QOL scale developed by Suzukamo et al. [ 16 , 17 ] to assess the QOL of GC patients after gastrectomy. This scale has been recognized for its simplicity and reliability in evaluating diet-related QOL among patients with conditions such as diabetes and osteoporosis [ 30 , 31 ]. In our study, the diet-related QOL scores for “Dietary satisfaction,” “Enjoyment of meals,” and “Dietary environment” all increased after 4 weeks of Opti Meal consumption. The Opti Meal provided in this study closely resembled regular meals in both appearance and taste. In addition, patients were able to choose from a variety of Opti Meal options according to their individual preferences, which likely contributed to increased satisfaction and enjoyment of meals. After 4 weeks of Opti Meal consumption, improvements in QOL scores were also observed in two domains: “Vitality” and “Mental health.” The satisfaction and enjoyment derived from the Opti Meal are believed to have contributed to these improvements in mental health–related QOL. To our knowledge, this study is the first to report that an Opti Meal intervention can improve diet-related QOL in patients who have undergone gastrectomy for GC. Additionally, analysis of diet-related QOL scores by surgical procedure revealed a significant improvement in the “Enjoyment of meals” domain among patients who underwent total gastrectomy. Previous studies have reported that postoperative QOL is significantly lower after total gastrectomy than after partial or distal gastrectomy [ 32 – 34 ]. In particular, patients who undergo total gastrectomy often face greater dietary restrictions, so consuming Opti Meals may have enhanced their enjoyment of eating. During the intervention period, no adverse events related to Opti Meal consumption were recorded in patients’ food diaries or detected through blood tests. These findings indicate that patients who had undergone gastrectomy were able to safely consume the Opti Meal, comparable to healthy individuals. This study has two main limitations. First, it was a single-center study with a limited number of participants. In particular, the numbers of patients who underwent proximal gastrectomy and pylorus-preserving gastrectomy were extremely small. Prospective, randomized clinical trials will be needed to further evaluate whether Opti Meal intervention can improve postoperative diet-related QOL in patients who have undergone gastrectomy. Second, diet-related QOL was evaluated at only a single time point—4 weeks after Opti Meal consumption. Future studies should investigate how long the effects of the Opti Meal intervention persist over time. Conclusions A 4-week Opti Meal intervention in patients who had undergone gastrectomy for GC did not improve nutritional status or prevent weight loss. However, it suggested the potential to improve diet-related quality of life. Declarations Author Contribution Statement Study concept: Motohiro Imano; study design: Motohiro Imano; data acquisition: Masayuki Shinkai, Yoko Hiraki, Naoko Kounami, Masuhiro Terada, Atsushi Yamada, Masashi Kohda, Tomoya Nakanishi, Hiroaki Kato, Osamu Shiraishi and Atsushi Yasuda; statistical analysis: Yoko Hiraki, Shintaro Fujii, Jun Iimura and Futoshi Nakamura; data analysis and/or interpretation: Masayuki Shinkai, Motohiro Imano and Yoko Hiraki; drafting of the manuscript: Masayuki Shinkai and Motohiro Imano; critical revision of the manuscript for important intellectual content: Takushi Yasuda. All authors approved the final version of the manuscript. Ethical Approval All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later version. The ethics committee of Kindai Hospital approved the study (Approval No. R04-227). Competing Interests The authors report no potential conflict of interest. Funding Nissin Food Products Co., Ltd. funded this research and provided the test food. Author Contribution MS and MI wrote the main manuscript text . SF and JI and FN prepared figure 1. YH and NK and MT prepared table 1. AY and MK and TN prepared table 2. HK and OS prepared table 3. AY and TY prepared table 4. All authors reviewed the manuscript. Acknowledgement The authors wish to thank all patients who contributed their data for analysis in the present study. The authors also thank Angela Morben, DVM, ELS, from Edanz (https://jp.edanz.com/ac), for editing a draft of this manuscript. 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Shimonosono M, Arigami T, Matsushita D, Tsuruda Y, Sasaki K, Baba K, et al (2024) Evaluation of quality of life and prognosis of gastric cancer patients after laparoscopic subtotal gastrectomy. Anticancer Res 44:386–396. Miki Y, Bito T, Koterazawa Y, Kanaji S, Shinohara H (2025) Advantages of subtotal gastrectomy for upper third gastric cancer: A systematic review and meta-analysis. Ann Gastroenterol Surg 9:650–657. Tables Table 1 to 4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1Shinkai.docx Table2Shinkai.docx Table3Shinkai.docx Table4Shinkai.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 19 Dec, 2025 Editor assigned by journal 19 Dec, 2025 Submission checks completed at journal 08 Dec, 2025 First submitted to journal 26 Nov, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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1","display":"","copyAsset":false,"role":"figure","size":115967,"visible":true,"origin":"","legend":"\u003cp\u003eDiet-Related Quality of Life Scale (General Use) Utilization Questionnaire\u003c/p\u003e","description":"","filename":"Fig1Shinkai1.png","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/d0a94134d9f75d8431ff611c.png"},{"id":98783470,"identity":"c32d34c4-263b-4051-80b9-aca287ae1d10","added_by":"auto","created_at":"2025-12-22 12:42:00","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":771950,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/128a6921-dc07-4762-8831-100485be2277.pdf"},{"id":98771088,"identity":"eab9708e-b9d0-4a5c-b58e-b20ccb16d91f","added_by":"auto","created_at":"2025-12-22 10:40:10","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":21012,"visible":true,"origin":"","legend":"","description":"","filename":"Table1Shinkai.docx","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/948ec0ec1845f1f9090c40ba.docx"},{"id":98771134,"identity":"fe2eaf67-ed53-4e5a-9525-48ffd6e3c90b","added_by":"auto","created_at":"2025-12-22 10:40:12","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":22769,"visible":true,"origin":"","legend":"","description":"","filename":"Table2Shinkai.docx","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/22195e991eef5ca48500aa65.docx"},{"id":98770954,"identity":"203a26d6-fdeb-486e-82a6-0f10e7f5931b","added_by":"auto","created_at":"2025-12-22 10:40:04","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":18172,"visible":true,"origin":"","legend":"","description":"","filename":"Table3Shinkai.docx","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/26d61ed2ae8902986aa484b2.docx"},{"id":98771074,"identity":"857287f6-df1f-43b4-9e50-d2853f82d496","added_by":"auto","created_at":"2025-12-22 10:40:09","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":25658,"visible":true,"origin":"","legend":"","description":"","filename":"Table4Shinkai.docx","url":"https://assets-eu.researchsquare.com/files/rs-8216854/v1/fc1ea8006a49d65caea5e6da.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Investigating the impact of Optimized Nutri-Dense Meals on diet-related quality of life after gastrectomy for gastric cancer","fulltext":[{"header":"Introduction","content":"\u003cp\u003eGastric cancer (GC) is the fifth most common cancer worldwide and the fourth leading cause of cancer-related death [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Gastrectomy remains a highly effective treatment for GC; however, patients who undergo this procedure often experience reduced appetite and food intake due to microgastric symptoms and decreased ghrelin secretion, leading to body weight loss (BWL) [\u003cspan additionalcitationids=\"CR3 CR4 CR5\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePost-gastrectomy BWL has been linked to impaired quality of life (QOL), poor adherence to adjuvant chemotherapy, and unfavorable prognosis [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Consequently, several studies have investigated the potential of oral nutritional supplements (ONS) to prevent BWL in gastrectomy patients, yet the effectiveness of ONS in mitigating weight loss remains inconclusive [\u003cspan additionalcitationids=\"CR9 CR10\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePostoperative GC patients experience not only post-gastrectomy syndromes such as esophageal reflux, abdominal pain, lethargy, diarrhea, constipation, and dumping syndrome [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], but also a marked decline in QOL\u0026mdash;particularly in aspects related to eating, such as hunger, early satiety, and fewer opportunities to enjoy food. We believe that improving the diet-related QOL of post-gastrectomy patients is an important clinical goal.\u003c/p\u003e \u003cp\u003eRecently, \u0026ldquo;Optimized Nutri-Dense Meals\u0026rdquo; (Opti Meal) have been developed, designed to balance major nutrients according to individual factors such as age, sex, and lifestyle. This dietary intervention is based on 33 nutrients defined in Japan\u0026rsquo;s Dietary Reference Intakes [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSeveral studies have reported the benefits of Opti Meal interventions for individuals with elevated HbA1c levels and for frail patients [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Building on these findings, we hypothesized that dietary intervention using Opti Meal may also be beneficial for post-gastrectomy patients. In this study, we examined the effects of Opti Meal on diet-related QOL, body weight, and nutrition-related parameters in postoperative GC patients.\u003c/p\u003e"},{"header":"Material and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003e This 4-week, open-label intervention study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Ethics Committee of the Kindai University Faculty of Medicine, following the ethical guidelines for research involving humans established by the Ministry of Health, Labour and Welfare of Japan. The trial was registered in the UMIN Clinical Trials Registry (UMIN000051309). Informed consent was obtained from all participants, allowing publication of the study results under the condition that personal information would remain confidential.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy population\u003c/h3\u003e\n\u003cp\u003eThe eligibility criteria for this study were as follows: age of 18 years or older, history of gastrectomy for the treatment of GC, attendance at outpatient consultations approximately once per month, no evidence of GC recurrence, ability to consume an Opti Meal without difficulty, and provision of free and voluntary written consent after receiving full information about study participation.\u003c/p\u003e \u003cp\u003eThe exclusion criteria were as follows: irregular eating habits (e.g., skipping breakfast, lunch, or dinner); particularly selective or picky eating habits; presence of, or risk for, food allergies; and determination by the principal investigator that participation was unsuitable.\u003c/p\u003e\n\u003ch3\u003eInterventions\u003c/h3\u003e\n\u003cp\u003e The participants consumed an Opti Meal once every 2 days, choosing to take it as breakfast, lunch, dinner, or a snack over a 4-week period. Personal preferences were considered, and menu selections were discussed during the informed consent process. All test meals were delivered once every 2 weeks as frozen meal sets to be consumed at home. Each meal was designed to include 33 nutrients, as described in a previous study [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. There were no restrictions on snacks or alcohol consumption. Participants were asked to record the following information in a daily diary: meal details, amount of alcohol consumed, number of medications or health foods taken, level of physical activity, lifestyle changes, prohibited actions, and any symptoms observed.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcomes were changes in both quantitative and qualitative satisfaction with food, as well as overall subjective satisfaction. The secondary outcomes included changes in nutrition-related and other blood laboratory parameters, immunonutritional indicators, body weight, and the safety of Opti Meal consumption.\u003c/p\u003e\n\u003ch3\u003eProcedures\u003c/h3\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eDiet-related QOL scale\u003c/h2\u003e \u003cp\u003eDiet-related QOL was assessed using the tool developed by Suzukamo et al. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. This scale was designed to evaluate both quantitative and qualitative satisfaction with diet, as well as the impact of dietary changes on social life functions [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this study, we selected three items (Questions 1, 2, and 8) from the eight items of the original questionnaire developed by Suzukamo et al. [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] to assess the effect of Opti Meal on the diet-related QOL of GC patients after gastrectomy. The diet-related QOL scale comprises seven subscales: (1) Dietary satisfaction, (2) Enjoyment of meals, (3) Dietary environment, (4) Location change, (5) Overall meal feeling, (6) Vitality, and (7) Mental health.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSubscale structure\u003c/h3\u003e\n\u003cp\u003eDietary satisfaction consists of six items (Questions 1, 2, 7, 9, 15, and 16 in Question 1). Enjoyment of meals consists of five items (Questions 3, 4, 8, 13, and 14 in Question 1). Dietary environment consists of four items (Questions 5, 6, 11, and 12 in Question 1). Location change consists of one item (Question 10 in Question 1). Overall meal feeling corresponds to Question 2. Vitality consists of four items (Questions 1, 5, 7, and 9 in Question 8). Mental health consists of five items (Questions 2, 3, 4, 6, and 8 in Question 8) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eSubscales (1)\u0026ndash;(4) were designed to assess QOL directly related to dietary habits, while subscales (5)\u0026ndash;(7) were adapted from the Japanese version of the SF-36 [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] as a comprehensive measure of health-related QOL reflecting restrictions in daily life functions. Each item was rated on a 5-point Likert scale. Subscale scores were calculated by summing item scores and converting them to a 0\u0026ndash;100 scale, with higher scores indicating better QOL. In addition, the SF-36 Japanese version\u0026mdash;widely used as a comprehensive tool for evaluating health-related QOL\u0026mdash;was also administered, with higher scores again reflecting better QOL.\u003c/p\u003e\n\u003ch3\u003eLaboratory tests\u003c/h3\u003e\n\u003cp\u003eBlood samples were collected to measure total protein, albumin, cholinesterase, total cholesterol, triglycerides, and C-reactive protein.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eImmunonutritional indicator\u003c/h2\u003e \u003cp\u003eThe prognostic nutritional index (PNI) was calculated.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePhysical parameter\u003c/h2\u003e \u003cp\u003eBody weight was measured.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSafety\u003c/h2\u003e \u003cp\u003eSafety was assessed based on the occurrence of adverse events and the presence of abnormal test results.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eBecause this was an exploratory study, no formal sample size calculation was performed; the target number of participants was set at 40 based on feasibility. All measurements are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. Within-group comparisons were conducted using the Wilcoxon signed-rank test for diet-related QOL scales and paired t-tests for other continuous variables, comparing values at baseline and at 4 weeks post-intervention. Between-group comparisons were performed using the Mann\u0026ndash;Whitney U test for diet-related QOL scales and unpaired t-tests for other variables, focusing on the changes from baseline to 4 weeks post-intervention.\u003c/p\u003e \u003cp\u003eAll statistical tests were two-sided, with a significance level of 5%. Analyses were performed using BellCurve for Excel, version 4.06 (Social Survey Research Information Co., Ltd., Tokyo, Japan).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePatient characteristics\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBetween May 2023 and October 2023, 41 patients were recruited for this study. Two patients were excluded because they consumed less than 40% of an Opti Meal, leaving 39 patients for analysis. The baseline characteristics of these patients are shown in Table 1. Their median age was 74 years (range, 42\u0026ndash;86). Among the 39 patients, 20 had undergone total gastrectomy, 17 distal gastrectomy, 1 proximal gastrectomy, and 1 pylorus-preserving gastrectomy. The mean time from surgery to study intervention was 3.97 years (range, 1.36\u0026ndash;30.38).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEvaluation of various parameters\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBlood tests conducted after 4 weeks of Opti Meal consumption showed no significant changes in the red blood cell count, hematocrit, white blood cell (WBC) count, WBC fraction, or platelet count. However, a decrease in hemoglobin (Hb) levels was observed after consumption of the Opti Meal (p = 0.0111). Regarding nutrition-related laboratory data, there were no significant changes in total protein, albumin, cholinesterase, total cholesterol, or triglyceride levels after 4 weeks of Opti Meal consumption. The PNI was used as an immunonutritional assessment, and no increase in PNI values was observed after 4 weeks. Body weight was evaluated as a physical parameter, but no weight gain was observed following 4 weeks of Opti Meal intake (Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChanges in diet-related QOL with consumption of the Opti Meal\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe diet-related QOL before and after consumption of the Opti Meal is presented in Table 3. The QOL score for \u0026ldquo;Dietary satisfaction\u0026rdquo; increased from 51.24 \u0026plusmn; 19.37 to 72.12 \u0026plusmn; 14.63 after 4 weeks of Opti Meal consumption (p = 0.0001). The score for \u0026ldquo;Enjoyment of meals\u0026rdquo; rose from 49.36 \u0026plusmn; 19.20 to 60.90 \u0026plusmn; 17.39 (p = 0.0012). The score for \u0026ldquo;Dietary environment\u0026rdquo; increased from 69.23 \u0026plusmn; 17.93 to 77.99 \u0026plusmn; 14.72 (p = 0.0034). By contrast, no significant changes were observed in the QOL scores for \u0026ldquo;Location change\u0026rdquo; or \u0026ldquo;Overall meal feeling\u0026rdquo; after 4 weeks of Opti Meal consumption. However, improvements were noted in the scores for \u0026ldquo;Vitality\u0026rdquo; and \u0026ldquo;Mental health\u0026rdquo; following the 4-week intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDiet-related QOL assessment by surgical procedure\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the total gastrectomy (TG) group, the QOL score for \u0026ldquo;Dietary satisfaction\u0026rdquo; increased from 47.42 \u0026plusmn; 19.14 to 71.46 \u0026plusmn; 15.07 after 4 weeks of Opti Meal consumption (p = 0.0001). In the distal gastrectomy (DG) group, the score increased from 57.11 \u0026plusmn; 19.25 to 73.28 \u0026plusmn; 14.88 after 4 weeks (p = 0.0013). However, no significant difference in \u0026ldquo;Dietary satisfaction\u0026rdquo; was observed between the TG and DG groups based on surgical procedure (p = 0.1018).\u003c/p\u003e\n\u003cp\u003eIn the TG group, the QOL score for \u0026ldquo;Enjoyment of meals\u0026rdquo; increased from 47.00 \u0026plusmn; 21.79 to 66.25 \u0026plusmn; 13.75 after 4 weeks (p = 0.0029). By contrast, in the DG group, the score remained largely unchanged, increasing from 52.06 \u0026plusmn; 17.24 to 55.59 \u0026plusmn; 20.45 after 4 weeks (p = 0.4096). Therefore, in terms of \u0026ldquo;Enjoyment of meals,\u0026rdquo; the TG group showed a significant improvement in meal-related QOL compared with the DG group (p = 0.0431).\u003c/p\u003e\n\u003cp\u003eIn the TG group, the QOL score for \u0026ldquo;Dietary environment\u0026rdquo; increased from 67.19 \u0026plusmn; 19.33 to 77.08 \u0026plusmn; 16.94 after 4 weeks (p = 0.0199). In the DG group, the score remained largely unchanged, rising slightly from 71.69 \u0026plusmn; 16.99 at baseline to 78.68 \u0026plusmn; 12.31 after 4 weeks (p = 0.1776). No significant difference in \u0026ldquo;Dietary environment\u0026rdquo; was observed between the TG and DG groups (p = 0.5293).\u003c/p\u003e\n\u003cp\u003eFor \u0026ldquo;Location change\u0026rdquo; and \u0026ldquo;Overall meal feeling,\u0026rdquo; neither the TG nor the DG group showed improvement in QOL after 4 weeks of Opti Meal consumption, and no differences were found between the groups.\u003c/p\u003e\n\u003cp\u003eRegarding \u0026ldquo;Vitality\u0026rdquo; and \u0026ldquo;Mental health,\u0026rdquo; improvements in QOL were observed in both the TG and DG groups after 4 weeks of Opti Meal intake, but no significant differences between the two groups were detected according to surgical procedure (Table 4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEvaluation of safety\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo symptoms such as moodiness, nausea, diarrhea, or abdominal pain were observed that could be attributed to the consumption of the Opti Meal. Overall, no significant safety concerns were identified with the Opti Meal.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eFollowing gastrectomy, patients experience not only loss of appetite and weight loss but also a variety of post-gastrectomy symptoms resulting from reduced gastric storage capacity, decreased digestive function, and diminished ghrelin secretion [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. These factors collectively have a negative impact on patients\u0026rsquo; QOL after surgery. We believe that improving diet-related QOL is a particularly important aspect of the post-gastrectomy lifestyle for GC patients. Therefore, this study focused on diet-related QOL as a means to address this issue.\u003c/p\u003e \u003cp\u003eIn this study, we examined the effects of the Opti Meal on patients with GC who had undergone gastrectomy. The Opti Meal incorporates 33 essential nutrients and has been reported to help improve HbA1c levels in patients with diabetes and to aid in the prevention of frailty [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWe evaluated the blood data of post-gastrectomy GC patients after 4 weeks of Opti Meal consumption and found no changes in WBC, red blood cell, or platelet counts. However, a decrease in Hb levels was observed following the intervention. Because the Opti Meal provides the recommended daily amount of iron for Japanese individuals, the cause of this decline in Hb levels remains unclear but may have been influenced by seasonal factors. The intervention period for this study spanned from May to October, with many participants enrolled between July and September\u0026mdash;the peak of summer in Japan. Previous reports have shown that Hb concentration is inversely correlated with air temperature [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. In addition, sweating is known to contribute to iron deficiency anemia [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Therefore, increased perspiration due to the extreme summer heat may have been a contributing factor to the observed decrease in Hb levels.\u003c/p\u003e \u003cp\u003eThe 4-week Opti Meal intervention did not produce any changes in nutrition-related indicators such as albumin or cholesterol levels. Similarly, previous studies investigating ONS intake (300\u0026ndash;400 kcal/day) in post-gastrectomy patients have also reported no significant improvements in nutritional parameters [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Although the Opti Meal contains 33 nutrients and provides 367\u0026ndash;572 kcal per meal, we believe that a 4-week intervention period may be insufficient to produce measurable improvements in nutritional status.\u003c/p\u003e \u003cp\u003eIn this study, we evaluated the immunonutritional effects of the Opti Meal intervention using the PNI. The PNI, calculated from serum albumin concentration and peripheral blood lymphocyte count, serves as an indicator of the nutritional and immunological status of patients with various cancers [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. The preoperative PNI has been identified as a predictive marker for both long-term prognosis and short-term outcomes in patients with GC [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Moreover, recent studies have reported that improved postoperative PNI levels in patients with gastrointestinal cancer are associated with a better prognosis [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Therefore, we consider postoperative improvement in the PNI to be an important goal for patients with GC. In this study, however, no changes were observed in albumin levels or lymphocyte counts after 4 weeks of Opti Meal consumption, and consequently, no improvement in PNI values was detected. Further investigation will be needed to determine whether extending the intervention period may lead to improvements in the PNI.\u003c/p\u003e \u003cp\u003eAdditionally, the 4-week Opti Meal intervention did not result in any changes in body weight. Omori et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] reported that patients who received ONS supplementation for 3 months after gastrectomy experienced less weight loss than those in the control group. Therefore, the weight-preserving effect of the Opti Meal intervention may have been too modest to produce measurable results within a 4-week period.\u003c/p\u003e \u003cp\u003eAnother possible explanation is that weight loss after gastrectomy is time-dependent, being most pronounced during the first 3 months postoperatively [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Based on this, Omori et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] initiated ONS supplementation within 3 days of patients resuming normal oral intake after surgery. By contrast, all participants in our study had undergone surgery more than 1 year prior to the intervention, suggesting that the Opti Meal dietary intervention may have had little effect on body weight in this population.\u003c/p\u003e \u003cp\u003eIn this study, we used the diet-related QOL scale developed by Suzukamo et al. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] to assess the QOL of GC patients after gastrectomy. This scale has been recognized for its simplicity and reliability in evaluating diet-related QOL among patients with conditions such as diabetes and osteoporosis [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In our study, the diet-related QOL scores for \u0026ldquo;Dietary satisfaction,\u0026rdquo; \u0026ldquo;Enjoyment of meals,\u0026rdquo; and \u0026ldquo;Dietary environment\u0026rdquo; all increased after 4 weeks of Opti Meal consumption.\u003c/p\u003e \u003cp\u003eThe Opti Meal provided in this study closely resembled regular meals in both appearance and taste. In addition, patients were able to choose from a variety of Opti Meal options according to their individual preferences, which likely contributed to increased satisfaction and enjoyment of meals. After 4 weeks of Opti Meal consumption, improvements in QOL scores were also observed in two domains: \u0026ldquo;Vitality\u0026rdquo; and \u0026ldquo;Mental health.\u0026rdquo; The satisfaction and enjoyment derived from the Opti Meal are believed to have contributed to these improvements in mental health\u0026ndash;related QOL. To our knowledge, this study is the first to report that an Opti Meal intervention can improve diet-related QOL in patients who have undergone gastrectomy for GC.\u003c/p\u003e \u003cp\u003eAdditionally, analysis of diet-related QOL scores by surgical procedure revealed a significant improvement in the \u0026ldquo;Enjoyment of meals\u0026rdquo; domain among patients who underwent total gastrectomy. Previous studies have reported that postoperative QOL is significantly lower after total gastrectomy than after partial or distal gastrectomy [\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. In particular, patients who undergo total gastrectomy often face greater dietary restrictions, so consuming Opti Meals may have enhanced their enjoyment of eating.\u003c/p\u003e \u003cp\u003eDuring the intervention period, no adverse events related to Opti Meal consumption were recorded in patients\u0026rsquo; food diaries or detected through blood tests. These findings indicate that patients who had undergone gastrectomy were able to safely consume the Opti Meal, comparable to healthy individuals.\u003c/p\u003e \u003cp\u003eThis study has two main limitations. First, it was a single-center study with a limited number of participants. In particular, the numbers of patients who underwent proximal gastrectomy and pylorus-preserving gastrectomy were extremely small. Prospective, randomized clinical trials will be needed to further evaluate whether Opti Meal intervention can improve postoperative diet-related QOL in patients who have undergone gastrectomy. Second, diet-related QOL was evaluated at only a single time point\u0026mdash;4 weeks after Opti Meal consumption. Future studies should investigate how long the effects of the Opti Meal intervention persist over time.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eA 4-week Opti Meal intervention in patients who had undergone gastrectomy for GC did not improve nutritional status or prevent weight loss. However, it suggested the potential to improve diet-related quality of life.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution Statement\u003c/h2\u003e \u003cp\u003eStudy concept: Motohiro Imano; study design: Motohiro Imano; data acquisition: Masayuki Shinkai, Yoko Hiraki, Naoko Kounami, Masuhiro Terada, Atsushi Yamada, Masashi Kohda, Tomoya Nakanishi, Hiroaki Kato, Osamu Shiraishi and Atsushi Yasuda; statistical analysis: Yoko Hiraki, Shintaro Fujii, Jun Iimura and Futoshi Nakamura; data analysis and/or interpretation: Masayuki Shinkai, Motohiro Imano and Yoko Hiraki; drafting of the manuscript: Masayuki Shinkai and Motohiro Imano; critical revision of the manuscript for important intellectual content: Takushi Yasuda. All authors approved the final version of the manuscript.\u003c/p\u003e \u003ch2\u003eEthical Approval\u003c/h2\u003e \u003cp\u003e All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later version. The ethics committee of Kindai Hospital approved the study (Approval No. R04-227).\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting Interests\u003c/strong\u003e \u003cp\u003eThe authors report no potential conflict of interest.\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eNissin Food Products Co., Ltd. funded this research and provided the test food.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eMS and MI wrote the main manuscript text . SF and JI and FN prepared figure 1. YH and NK and MT prepared table 1. AY and MK and TN prepared table 2. HK and OS prepared table 3. AY and TY prepared table 4. All authors reviewed the manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors wish to thank all patients who contributed their data for analysis in the present study. The authors also thank Angela Morben, DVM, ELS, from Edanz (https://jp.edanz.com/ac), for editing a draft of this manuscript.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data that support the findings of this study are available on request from the corresponding author. The data are not publicly available because of privacy or ethical restrictions.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBay F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al (2024) Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 74(3):229\u0026ndash;263.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee HH, Park JM, Song KY, Choi MG, Park CH (2016) Survival impact of postoperative body mass index in gastric cancer patients undergoing gastrectomy. Eur J Cancer 52:129\u0026ndash;137.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMisawa K, Terashima M, Uenosono Y, Ota S, Hata H, Noro H, et al (2015) Evaluation of postgastrectomy symptoms after distal gastrectomy with Billroth-I reconstruction using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45). Gastric Cancer 18(3):675\u0026ndash;681.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K (1999) Ghelins is a growth-hormone-releasing acylated peptide from stomach. Nature 402:656\u0026ndash;660.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVan der Lery AJ, Tschop M, Heiman ML, Ghigo E (2004) Biological, physiological, pathophysiological, and pharmacological aspects of ghrelin. Endor Rev 25:426\u0026ndash;457.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTakachi K, Doki Y, Ishikawa O, Miyashiro I, Sasaki Y, Ohigashi H, et al (2006) Postoperative ghrelin levels and delayed recovery from body weight loss after distal or total gastrectomy. J Surg Res 130:1\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAoyama T, Yoshikawa T, Shirai J, Hayashi T, Yamada T, Tsuchida K, et al (2013) Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer. Ann Surg Oncol 20:2000\u0026ndash;2006.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eImamura H, Nishikawa K, Kishi K, Inoue K, Matsuyama J, Akamaru Y, et al (2016) Effect of an oral elemental nutritional supplement on post-gastrectomy body weight loss in gastric cancer patients: A randomized controlled clinical trial. Ann Surg Oncol 23:2929\u0026ndash;2935.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHatao F, Chen KY, Wu JM, Wang MY, Aikou S, Onoyama H, et al (2017) Randomized controlled clinical trial assessing the effects of oral nutritional supplements in postoperative gastric cancer patients. Langenbecks Arch Surg 402:203\u0026ndash;211.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIda S, Hiki N, Cho H, Samakaki K, Ito S, Fujitani K, et al (2017) Randomized clinical trial comparing standard diet with perioperative oral immunonutrition in total gastrectomy for gastric cancer. Br J Surg 104:377\u0026ndash;383.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKong SH, Lee HJ, Na J, Kim WG, Han DS, Park SH, et al (2018) Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial. Surgery 164:1263\u0026ndash;1270.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNakada K, Ikeda M, Takahashi M, Kinami S, Yoshida M, Uenosono Y, et al (2015) Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: Newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients. Gastric Cancer 18:147\u0026ndash;158.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNakazeko T, Shobako N, Hirano Y, Nakamura F, Honda K (2022) Novel dietary intervention program \u0026ldquo;COMB meal program\u0026rdquo; approaching health and presenteeism: Two pilot studies. J Funct Food 92:105050.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShobako N, Goto C, Nakagawa T, Yamato T, Kondo S, Nakamura F, et al (2022) Hypotensive and HbA1c reducing effect of novel dietary intervention program \u0026ldquo;COMB meal program\u0026rdquo;: Two randomized clinical trials. J Funct Food 98:105279.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNakazeko T, Shobako N, Shioya N, Iwama Y, Hirano Y, Fujii S, et al (2023) Frailty-preventing effect of an intervention program using a novel complete nutritional \u0026ldquo;COMB-FP Meal\u0026rdquo;: A pilot randomized control trial. Nutrients 15:4317.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuzukamo Y, Ono T, Fukuhara S (2000) Assessment of diet-related QOL [in Japanese]. Diabetes Journal 28:87\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuzukamo Y, Ono T, Fukuhara S (2001) Nutrition and eating habits for longevity-diet and quality of life [in Japanese]. Ger Med 39:461\u0026ndash;464.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFukuhara S, Bito S, Green J, Hisato A, Kurokawa K (1998) Translation, adaptation, and validation of the SF-36 health survey for use in Japan. J Clin Epidemiol 51:1037\u0026ndash;1044.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFukuhara S, Ware JE, Kosinski M, Wada S, Gandeck B (1998) Psychometric and clinical tests of validity of the Japanese SF-36 health survey. J Clin Epidemiol 51:1045\u0026ndash;1053.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNeriishi S, Fukushima K, Sagawa LA (1973) Season variation in hemoglobin concentration and hematocrit value. Jap J Trop Med Hyg 1:39\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeeling P, Dawson B, Goodman C, Landers G, Trinder D (2008) Athletic induced iron deficiency: New insights into the role of inflammation, cytokines and hormones. Eur J Appl Physiol 103:381\u0026ndash;391.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKimura Y, Nishikawa K, Kishi K, Inoue K, Matsuyama J, Akamaru Y, et al (2019) Long-term effects of an oral elemental nutritional supplement on post-gastrectomy body weight loss in gastric cancer patients (KSES002). Ann Gastroenterol Surg 3:648\u0026ndash;656.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOmori T, Yamamoto K, Kurokawa Y, Miyazaki Y, Fujitani K, Kawabata R, et al (2024) Long-term effects of oral nutritional supplements after gastrectomy for gastric cancer: A survival analysis from a multicenter, open-label, randomized controlled trial. Ann Surg Oncol 31:6909\u0026ndash;6917.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNozoe T, Ninomiya M, Maeda T, Matsukuma A, Nakashima H, Ezaki T (2010) Prognostic nutritional index: A tool to predict the biological aggressiveness of gastric carcinoma. Surg Today 40:440\u0026ndash;443.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang Y, Gao P, Song Y, Sun J, Chen X, Zhao J, et al (2016) The prognostic nutritional index is a predictive indicator of prognosis and postoperative complications in gastric cancer: A meta-analysis. Eur J Surg Oncol 42:1176\u0026ndash;1182.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSasahara M, Kanda M, Ito S, Mochizuki Y, Teramoto H, Ishigure K, et al (2020) The preoperative prognostic nutrition index predicts short-term and ling-term outcomes of patients with stage II/III gastric cancer: Analysis of a multi-institution dataset. Dig Surg 37:135\u0026ndash;144.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKakiuchi Y, Kuroda S, Choda Y, Otsuka S, Ueyama S, Tanaka N, et al (2023) Prognostic nutritional index is a prognostic factor for patients with gastric cancer and esophagogastric junction cancer undergoing proximal gastrectomy with esophagogastrostomy by the double-flap technique: A secondary analysis of the rDL-FLAP study. Surg Oncol 50:101990.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee JM, Kang J (2025) Combining preoperative and postoperative prognostic nutritional index as an improved prognostic factor for overall survival in patients with colorectal cancer. J Inflammation Res 18:8935\u0026ndash;8944.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee JH, Hyung WJ, Kim HI, Kim YM, Son T, Okamura N, et al (2013) Method of reconstruction governs iron metabolism after gastrectomy for patients with gastric cancer. Ann Surg 258(6):964\u0026ndash;969.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSato E, Miyashita M, Suzukamo Y, Kazuma K (2004) Development of a diabetes diet-related quality-of-life scale. Diabetes Care 27(6):1271\u0026ndash;1275.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatsumoto Y, Wakano C, Kimura T, Nishioka E, Yunoki N, Kurokawa M (2025) Diet-related quality of life may directly and indirectly affect health-related quality of life through protein intake and frailty in patients with osteoporosis: Results from a prospective cohort study. Geriatr Gerontol 25(2):243\u0026ndash;250.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNunobe S, Takahashi M, Kinami S, Fujita J, Suzuki T, Suzuki A, et al (2022) Evaluation of postgastrectomy symptoms and daily lives of small remnant distal gastrectomy for upper-third gastric cancer using a large-scale questionnaire survey. Ann Gastroenterol Surg 6:355\u0026ndash;365.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShimonosono M, Arigami T, Matsushita D, Tsuruda Y, Sasaki K, Baba K, et al (2024) Evaluation of quality of life and prognosis of gastric cancer patients after laparoscopic subtotal gastrectomy. Anticancer Res 44:386\u0026ndash;396.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMiki Y, Bito T, Koterazawa Y, Kanaji S, Shinohara H (2025) Advantages of subtotal gastrectomy for upper third gastric cancer: A systematic review and meta-analysis. Ann Gastroenterol Surg 9:650\u0026ndash;657.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 to 4 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"diet-related quality of life, Opti Meal, gastric cancer, gastrectomy","lastPublishedDoi":"10.21203/rs.3.rs-8216854/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8216854/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eGastrectomy is an essential component of gastric cancer treatment. However, it is often accompanied by appetite loss, reduced food intake, malabsorption, and body weight loss, which inevitably contribute to a decline in diet-related quality of life (QOL). In this study, we investigated the effects of Optimized Nutri-Dense Meals (Opti Meal) on patients following gastrectomy. Opti Meal is a newly developed balanced diet containing 33 essential nutrients.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThirty-nine patients who had undergone gastrectomy for gastric cancer consumed one serving of Opti Meal every other day for 4 weeks. Changes in diet-related QOL scores, body weight, blood test parameters, and the safety of Opti Meal were evaluated.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe 39 participants comprised 20 patients who underwent total gastrectomy, 17 distal gastrectomy, 1 proximal gastrectomy, and 1 pylorus-preserving gastrectomy. No changes in body weight or nutrition-related laboratory data were observed after Opti Meal consumption. However, diet-related QOL scores\u0026mdash;including enjoyment of meals, dietary satisfaction, dietary environment, vitality, and mental health\u0026mdash;increased significantly after 4 weeks of Opti Meal intake. By surgical procedure, patients who underwent total gastrectomy showed a significantly greater improvement in \u0026ldquo;enjoyment of meals\u0026rdquo; compared with those in other surgical groups. No safety issues were identified with Opti Meal consumption.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eDietary intervention with Opti Meal may be beneficial for improving diet-related QOL after gastrectomy for gastric cancer.\u003c/p\u003e","manuscriptTitle":"Investigating the impact of Optimized Nutri-Dense Meals on diet-related quality of life after gastrectomy for gastric cancer","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-22 10:38:53","doi":"10.21203/rs.3.rs-8216854/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2025-12-19T14:54:17+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-12-19T14:52:38+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-12-08T21:48:58+00:00","index":"","fulltext":""},{"type":"submitted","content":"Supportive Care in Cancer","date":"2025-11-27T01:23:29+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"786632bf-eb80-4617-baf9-9cd79ac9697c","owner":[],"postedDate":"December 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T10:38:53+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-22 10:38:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8216854","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8216854","identity":"rs-8216854","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}