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IRCT20170202032367N8 IRCT 2023-03-28 Tehran University of Medical Sciences LJCarbohydrate-restricted diet in inflammatory bowel disease Investigating the effect of modified specific carbohydrate diet on disease severity, fecal calprotectin level and disability caused by the disease in people with ulcerative colitis. 2023-04-22 anticipated 42 Complete https://irct.ir/trial/68603 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. N/A 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.Before the start of the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake.During this period, 2 24-hour food reminders including two working days and one day off per week are completed. The physical activity of the patients will be recorded through the IPAQ questionnaire.All people will be asked not to change their physical activity and medication during the study compared to before the study and to avoid smoking during the study. The severity of the disease, fecal calprotectin level and disability caused by the disease will be evaluated at the beginning and end of the study.Important points during the prescribed modified specific carbohydrate diet:1- The consumption of any kind of bread prepared from wheat flour during this period is prohibited. 2- The use of wheat flour in the preparation of daily meals is prohibited. 3- It is forbidden to use any kind of cake, cookies, biscuits, etc. made from wheat flour. 4- It is forbidden to consume any kind of milk and products containing milk. 5- It is forbidden to consume all kinds of cheese except old cheeses that have There are small amounts of lactose.6- It is forbidden to consume all types of yogurt, except the leftover and old yogurts that contain small amounts of lactose. 7- In the cereal group, the use of oats, rice and quinoa is free. 8- There are no restrictions on the type of oils. 9- The consumption of food with preservatives is prohibited. 10- The consumption of all kinds of meats is free, except processed meats such as sausages, sausages, etc. 11. The consumption of artificial sweeteners and foods that have been prepared with these sweeteners is prohibited. 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.Before the start of the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake.During this period, 2 24-hour food reminders including two working days and one day off per week are completed. The physical activity of the patients will be recorded through the IPAQ questionnaire.All people will be asked not to change their physical activity and medication during the study compared to before the study and to avoid smoking during the study. The severity of the disease, fecal calprotectin level and disability caused by the disease will be evaluated at the beginning and end of the study. 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 Mohammadreza Saboori
Unit 1, No. 9, Kouchetan 1st Street, Pasdaran, Tehran
Tehran Iran (Islamic Republic of) 1958844153 +98 21 2665 2428 Mohammadreza.saboori96@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 K51 Ulcerative colitis 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.Before the start of the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake.During this period, 2 24-hour food reminders including two working days and one day off per week are completed. The physical activity of the patients will be recorded through the IPAQ questionnaire.All people will be asked not to change their physical activity and medication during the study compared to before the study and to avoid smoking during the study. The severity of the disease, fecal calprotectin level and disability caused by the disease will be evaluated at the beginning and end of the study.Important points during the prescribed modified specific carbohydrate diet:1- The consumption of any kind of bread prepared from wheat flour during this period is prohibited. 2- The use of wheat flour in the preparation of daily meals is prohibited. 3- It is forbidden to use any kind of cake, cookies, biscuits, etc. made from wheat flour. 4- It is forbidden to consume any kind of milk and products containing milk. 5- It is forbidden to consume all kinds of cheese except old cheeses that have There are small amounts of lactose.6- It is forbidden to consume all types of yogurt, except the leftover and old yogurts that contain small amounts of lactose. 7- In the cereal group, the use of oats, rice and quinoa is free. 8- There are no restrictions on the type of oils. 9- The consumption of food with preservatives is prohibited. 10- The consumption of all kinds of meats is free, except processed meats such as sausages, sausages, etc. 11. The consumption of artificial sweeteners and foods that have been prepared with these sweeteners is prohibited. 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.Before the start of the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intake.During this period, 2 24-hour food reminders including two working days and one day off per week are completed. The physical activity of the patients will be recorded through the IPAQ questionnaire.All people will be asked not to change their physical activity and medication during the study compared to before the study and to avoid smoking during the study. The severity of the disease, fecal calprotectin level and disability caused by the disease will be evaluated at the beginning and end of the study. Illness severity. Timepoint: Before the intervention and 6 weeks later. Method of measurement: 9-point partial Mayo score questionnaire. Fecal calprotectin levels. Timepoint: Before the intervention and 6 weeks later. Method of measurement: Eliza kit. Disability due to illness. Timepoint: Before the intervention and 6 weeks later. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2023-02-11 Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee) Faculty of Nutrition Sciences and Dietetics, Hojat Dost Alley, Khanaderi, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)