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IRCT20100524004010N41 IRCT 2025-03-24 Shahid Beheshti University of Medical Sciences The Effect of low-FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet on clinical symptoms and quality of life in patients with non-ulcer dyspepsia: a randomized controlled trial The Effect of low-FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet on clinical symptoms and quality of life in patients with non-ulcer dyspepsia: a randomized controlled trial 2025-04-05 anticipated 50 Complete https://irct.ir/trial/82388 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the random allocation of participants into the intervention and control groups, each individual will be assigned a numerical code, which will then be entered into a table of random numbers. Based on the first randomly selected number from the table, participants will be sequentially assigned to one of the two groups. This process will continue until all participants have been allocated to either group. Randomization will be conducted by an individual independent of the intervention team to ensure impartiality, Blinding description: Collected data will be coded (e.g., Group A and Group B) before being provided to the data analysts. Statistical analyses will be conducted without knowledge of group allocation. This approach prevents potential bias in the interpretation of results. N/A non-ulcer dyspepsia. Intervention 1: Control group: The control group will continue their regular weight-maintenance diet without any restrictions on FODMAP intake for 12 weeks. Clinical symptoms and quality of life will be assessed at baseline and after 4 weeks using standardized questionnaires. This diet includes the following guidelines: 1. Eat slowly and regularly. 2. Reduce fat intake. 3. Follow a diet that closely resembles the Mediterranean diet or increase the consumption of fresh foods while reducing ultra-processed foods. 4. Avoid triggers such as spicy foods, carbonated drinks, tea, coffee, alcohol, smoking, and NSAIDs. 5. Consume small, frequent meals. Intervention 2: Intervention group: The intervention group will follow a weight-maintenance diet with low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (Low FODMAP), designed by a registered dietitian. This diet includes restrictions on foods high in FODMAPs, such as legumes, dairy products, certain fruits, and vegetables. In **Phase I (Weeks 0–4)**, patients in both groups will receive comprehensive oral and written dietary instructions from a trained dietitian. These instructions will include detailed recommendations on which foods to avoid or reduce and suitable alternatives. The dietitian will contact patients at the end of weeks 1, 4, and 12 to address any questions or concerns and to collect 3-day food records. Additionally, patients will have unlimited access to the dietitian for further consultation. In **Phase II (Weeks 5–12)**, after four weeks, a 3-day food record and symptom assessment will be collected. Patients will also complete the **Short-Form Nepean Dyspepsia Index (SF-NDI) for quality of life** and the **Gastrointestinal Symptom Rating Scale (GSRS) for functional dyspepsia symptoms, including the functional dyspepsia module**. Patients whose 3-day dietary recall shows a FODMAP intake of less than 20 grams will proceed to Phase II. The intervention group will receive revised instructions for continuing the low FODMAP diet, while the control group will continue following their initial dietary guidelines. At the **end of the study (Week 12)**, a 3-day food record and symptom assessment will again be collected, and patients will complete the **SF-NDI and GSRS (functional dyspepsia and dyspepsia module)**. Dietary compliance and any adverse effects will be recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided how to share the final data.
public Azita Hekmatdoost
No 7, Shahid Hafezi Ave, Farahzadi Blvd, Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No 7, Shahid Hafezi Ave, Farahzadi Blvd, Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Diagnosis of functional dyspepsia based on Rome IV criteria History of dyspeptic symptoms for at least 6 months Willingness and ability to adhere to the Low FODMAP Diet (LFD) No other gastrointestinal diseases, such as Crohn’s disease, ulcerative colitis, or celiac disease No regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) Not pregnant or breastfeeding 18 years no limit Both Unwillingness to continue the study Non-adherence to the intervention The occurrence of any serious adverse effects Becoming pregnant Development of any new gastrointestinal disease Regular use of NSAIDs K30 Functional dyspepsia Other Other Control group: The control group will continue their regular weight-maintenance diet without any restrictions on FODMAP intake for 12 weeks. Clinical symptoms and quality of life will be assessed at baseline and after 4 weeks using standardized questionnaires. This diet includes the following guidelines: 1. Eat slowly and regularly. 2. Reduce fat intake. 3. Follow a diet that closely resembles the Mediterranean diet or increase the consumption of fresh foods while reducing ultra-processed foods. 4. Avoid triggers such as spicy foods, carbonated drinks, tea, coffee, alcohol, smoking, and NSAIDs. 5. Consume small, frequent meals. Intervention group: The intervention group will follow a weight-maintenance diet with low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (Low FODMAP), designed by a registered dietitian. This diet includes restrictions on foods high in FODMAPs, such as legumes, dairy products, certain fruits, and vegetables. In **Phase I (Weeks 0–4)**, patients in both groups will receive comprehensive oral and written dietary instructions from a trained dietitian. These instructions will include detailed recommendations on which foods to avoid or reduce and suitable alternatives. The dietitian will contact patients at the end of weeks 1, 4, and 12 to address any questions or concerns and to collect 3-day food records. Additionally, patients will have unlimited access to the dietitian for further consultation. In **Phase II (Weeks 5–12)**, after four weeks, a 3-day food record and symptom assessment will be collected. Patients will also complete the **Short-Form Nepean Dyspepsia Index (SF-NDI) for quality of life** and the **Gastrointestinal Symptom Rating Scale (GSRS) for functional dyspepsia symptoms, including the functional dyspepsia module**. Patients whose 3-day dietary recall shows a FODMAP intake of less than 20 grams will proceed to Phase II. The intervention group will receive revised instructions for continuing the low FODMAP diet, while the control group will continue following their initial dietary guidelines. At the **end of the study (Week 12)**, a 3-day food record and symptom assessment will again be collected, and patients will complete the **SF-NDI and GSRS (functional dyspepsia and dyspepsia module)**. Dietary compliance and any adverse effects will be recorded. Clinical symptoms. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Quality of life. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Upper Abdominal Pain. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Bloating. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Early Satiety. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Nausea. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Belching. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia. Has your general emotional well-being been disturbedby your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Have you been irritable, tense or frustrated in thelast 2 weeks because of your stomach problems?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your ability to engage in things you usually do for fun (recreations, going out, hobbies, sports, etc.) been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your enjoyment of things you usually do for fun (recreations, going out, hobbies, sports, etc.) been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your ability to eat or drink (including when, what, and how much) been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your enjoyment of eating and/or drinking been disturbed by your stomach problems in the last 2 weeks? (Please also include your appetite, and howyou feel after food or drink). Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Have you wondered whether you will always have these stomach problems, in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Have you thought that your stomach problems might be due to a very serious illness (e.g. cancer or a heart problem), in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your ability to work or study been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Has your enjoyment of work or study been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). Shahid Beheshti University of Medical Sciences Approved 2025-01-22 Ethics Committee of National Nutrition and Food Technology Research Institute (NNFTRI) #7, Shahid Hafezi Ave, Farahzadi Blvd, Shahrak Gharb Tehran Tehran Iran (Islamic Republic of)