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IRCT20100524004010N38 IRCT 2023-04-25 Shahid Beheshti University of Medical Sciences The effects of combined Mediterranean, gluten-free, lactose-free and low-FODMAP diets accompanied with supplemental formula, and with the consumption of turmeric in patients with ulcerative colitis. The effects of combined Mediterranean, gluten-free, lactose-free and low-FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diets accompanied with supplemental formula, and with the consumption of turmeric on quality of life, disease activity index and serum level of some inflammatory factors and oxidative stress in patients with ulcerative colitis. 2023-04-21 anticipated 50 Complete https://irct.ir/trial/69463 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used in this study to create a randomization process is simple randomization, so we utilize random number table. Beginning of the study, each person is randomly assigned to one of the 2 study groups using random number generator software. 2-3 ulcerative colitis. Intervention 1: Intervention group: After calculating the amount of calories needed by each person using the Meflin formula, a diet with 75% of the calories needed to maintain weight is set based on the principles of the Mediterranean diet, gluten-free, lactose-free, low FODMAP and turmeric consumption. The remaining 25% is provided by standard formulas for 6 weeks. Intervention 2: Control group: After calculating the amount of calories needed by each person, using the Mefflin formula, the usual food plan is adjusted according to the calories needed to maintain weight for 6 weeks. 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, West Arghavan Ave., Farahzadi Blvd., 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, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Samples with inflammatory bowel disease confirmed by histopathology The duration of the disease is less than two years The disease is active in a mild to moderate stage (diagnosis of the severity of the disease is the responsibility of the treating physician) Not consuming alcohol and drugs Not suffering from other diseases and intestinal disorders, known autoimmune diseases, cancer, inflammatory and infectious diseases Not using multivitamin-mineral, omega-3, polyphenolic and antioxidant supplements, probiotics as well as the non-use of anticoagulants such as heparin and warfarin, NSAIDs such as ibuprofen, aspirin and diclofenac, antihistamines and calcium channel antagonists such as nifedipine in the past month BMI over 18.5 and under 30 Age 18 years and above No change in the type and dosage of the drug consumed during the past month Not having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent Willingness to participate in the study 18 years 70 years Both Recurrence of the disease in a way that leads to the hospitalization of the patient Suffering from other diseases such as biliary disease, kidney diseases, known autoimmune diseases, cancer and liver disorders The presence of abscesses or abdominal fistulas A history of ileostomy and colostomy Pregnancy or breastfeeding in women or Using birth control pills Receiving tube or intravenous feeding Following special diets and vegetarianism during the last 3 months Unwillingness to continue cooperation K51.9 Ulcerative colitis, unspecified Treatment - Other Placebo Intervention group: After calculating the amount of calories needed by each person using the Meflin formula, a diet with 75% of the calories needed to maintain weight is set based on the principles of the Mediterranean diet, gluten-free, lactose-free, low FODMAP and turmeric consumption. The remaining 25% is provided by standard formulas for 6 weeks. Control group: After calculating the amount of calories needed by each person, using the Mefflin formula, the usual food plan is adjusted according to the calories needed to maintain weight for 6 weeks. Serum hs-CRP. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Elisa. TNF-α. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Elisa. TAC. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Elisa. Life Quality. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Questionnaire. Disease Activity Index. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Questionnaire. Weight. Timepoint: At the first of research and end of research( 6th week). Method of measurement: scale. BMI. Timepoint: At the first of research and end of research( 6th week). Method of measurement: Calculation. Shahid Beheshti University of Medical Sciences Approved 2023-03-11 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)