]>
IRCT20181126041763N1 IRCT 2019-01-18 Tehran University of Medical Sciences Effect of flatulent carbohydrates restricted diet on gut microbium and inflammation in patients with ulcerative colitis FODMAP Effect of fermentable carbohydrates restricted diet on gut microbium and some inflammatory indices in patients with ulcerative colitis 2019-01-21 anticipated 32 Complete https://irct.ir/trial/35509 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: participants will be matched in terms of age (20 to 40 and 40 to 60 years), gender (male/female), body mass index (18.5 to 24.9 and 25 to 30) and drug type (anti-inflammatory (steroidal/anti-TNF) and immunosuppressant) in blocks composed of two patients in each blocks. Then, participants in each block will be randomly allocated to intervention or control groups. In order to randomize assignment of participants, each person will be given a specific code. Then, a person outside the study will be asked to draw the code out of a pot using the lottery. Participant with the first draw out code will be allocated to the intervention group, and the second code as the control; in order the rest of participants will be randomly assigned to the two groups. N/A Inflammatory Bowel Disease (Ulcerative Colitis). Intervention 1: Intervention group: Low-FODMAP diet in addition to general recommendations for IBD patients. Firstly, the basal metabolic rate (BMR) of the patients will be calculated using their age, sex, height and weight by the Harris Benedict formula. Then, daily energy requirement of each individual is calculated based on his/her physical activity when considering the thermogenic effect of foods (TEF). The macronutrient composition of this diet includes 55% energy from carbohydrates, 25% from fats, and 20% from proteins. Then, required values ​​from each food group will be calculated. In each food group, food items with high FODMAP will be discarded, and the remaining foods will be divided into 6 meals/day, including 3 main meals and 3 snacks. Accordingly, a two-week meal menu will be set up that patients will continue it for two additional weeks (a total of 4 weeks). Intervention 2: Control group: General recommendations for patients with IBD including recommendations to have physical activity, timely disposing of feces, consumption of low-fat dairies and meats, consumption of vegetable oils, and reduction in consumption of refined sugars. No - There is not a plan to make this available Justification or reason for not sharing IPD is No additional information are available
public Alireza Milajerdi
Enghelab street
Tehran Iran (Islamic Republic of) 14155-6559 +98 21 8889 6696 amkhv@yahoo.com Tehran University of Medical Sciences scientific Ahmad Esmaillzadeh
School of Nutritional Sciences and dietetics, Hojatdoost Ave., Naderi street, Keshavarz Blv, Tehran
Tehran Iran (Islamic Republic of) 14155-6559 +98 21 8895 5805 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age over than 20 and under 60 years Moderate ulcerative colitis (ulcerative colitis diagnosis will be done by a gastroenterologist, using the Mayo score) who are on stable drug therapy. The scores of 6-8 will be considered as moderate UC. BMI 18.5 to 30 kg/m2 20 years 60 years Both Changed in the type or dosage of their drugs over the past month Suffered from other gastrointestinal diseases including cancers and infectious diseases Pregnant or breastfeeding women or those with a decision for pregnancy in the near future Use of antibiotics Consumed pre- or pro-biotic products during the last two months Use tobacco or smoke Hospitalized in the last three months Infection over the past 3 months Suffering from any inflammation-promoting condition Used multi-vitamin and mineral supplements during the past month K51 Ulcerative colitis Treatment - Other N/A Intervention group: Low-FODMAP diet in addition to general recommendations for IBD patients. Firstly, the basal metabolic rate (BMR) of the patients will be calculated using their age, sex, height and weight by the Harris Benedict formula. Then, daily energy requirement of each individual is calculated based on his/her physical activity when considering the thermogenic effect of foods (TEF). The macronutrient composition of this diet includes 55% energy from carbohydrates, 25% from fats, and 20% from proteins. Then, required values ​​from each food group will be calculated. In each food group, food items with high FODMAP will be discarded, and the remaining foods will be divided into 6 meals/day, including 3 main meals and 3 snacks. Accordingly, a two-week meal menu will be set up that patients will continue it for two additional weeks (a total of 4 weeks). Control group: General recommendations for patients with IBD including recommendations to have physical activity, timely disposing of feces, consumption of low-fat dairies and meats, consumption of vegetable oils, and reduction in consumption of refined sugars Gut microbiota. Timepoint: Before Intervention and 4 weeks later. Method of measurement: PCR Method. Inflammation. Timepoint: Before intervention and 4 weeks later. Method of measurement: ELISA kit. Tehran University of Medical Sciences Approved 2018-10-03 Ethics committee of Tehran University of Medical Sciences School of nutritional sciences and dietetics, Hojatdoost Ave., Naderi street, Keshavarz blv, Tehran Tehran Tehran Iran (Islamic Republic of)