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IRCT20170202032367N7 IRCT 2023-03-01 Tehran University of Medical Sciences Carbohydrate-restricted diet in inflammatory bowel disease MSCD Investigating the effect of modified specific carbohydrate diet on nutritional status, disease and quality of life in patients with ulcerative colitis 2023-04-22 anticipated 42 Complete https://irct.ir/trial/68504 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the intervention, people will be placed in double blocks in terms of gender (male/female) and drug category.Random allocation of people placed in each block to intervention and non-intervention groups will be done.In order to randomly assign people to groups, each person is assigned a code and these codes are poured into a container. A person outside the study is then asked to draw codes from the container using a lottery. The first code will be assigned to the intervention group, the second code will be assigned to the control group, and the rest of the people will be randomly assigned to two groups. 1 Inflammatory bowel disease (ulcerative colitis). Intervention 1: Intervention group:People in the intervention group will receive a modified specific carbohydrate diet and essential tips during the diet to follow for 6 weeks. Intervention 2: Control group: People in the control group will follow their usual diet along with the nutritional recommendations related to their disease during these 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 There is no more information.
public Helia Moharrami
No. 14, 15th Street (Shaheed Yagoubi), Olympic Village, Tehran
Tehran Iran (Islamic Republic of) 1485964751 +98 990 445 4402 misshelia.1515@gmail.com Tehran University of Medical Sciences scientific Hossien Imani
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age above 20 and less than 60 years Patients with mild to moderate ulcerative colitis Willingness to participate in the study 20 years 60 years Both Changing the type of medicine used and its dosage during the last month Having other intestinal diseases (malignancies, infectious diseases) Suffering from other inflammatory diseases and kidney diseases and diabetes Pregnancy or breastfeeding Use of antibiotics, or use of pre- or probiotic products, or use of multivitamin and mineral supplements, or use of anti-inflammatory supplements such as w3 and curcumin during the intervention and in the one-month period before the intervention. Smoking and drug use History of hospitalization during the last three months Ulcerative K51 Treatment - Other Other Intervention group:People in the intervention group will receive a modified specific carbohydrate diet and essential tips during the diet to follow for 6 weeks. Control group: People in the control group will follow their usual diet along with the nutritional recommendations related to their disease during these 6 weeks. Nutritional status. Timepoint: Before the intervention and 6 weeks later. Method of measurement: Anthropometric measurements including weight, height, and BMI calculation will be done and will be included in the questionnaire. Inflammation. Timepoint: Before the intervention and 6 weeks later. Method of measurement: Eliza kit. Quality of Life. Timepoint: Before the intervention and 6 weeks later. Method of measurement: Inflammatory bowel disease questionnaire. Complete blood cell count. Timepoint: Before the intervention and 6 weeks later. Method of measurement: Auto Analyzer device. Tehran University of Medical Sciences Approved 2023-01-20 Ethics Committee of Tehran University of Medical Sciences Faculty of Nutrition Sciences and Dietetics, Hojat Dost Alley, Khanaderi, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)