The effects of cholecalciferol and soy isoflavones in irritable bowel syndrome
- Conditions
- Irritable Bowel Syndrome.Irritable colon
- Registration Number
- IRCT2013112915582N1
- Lead Sponsor
- ational Nutrition and Food Technology Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 100
age 18-75 yrs; patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria; BMI 18-25; no intestinal organic diseases; no intestinal infection; no history of chronic gastrointestinal and colorectal diseases; no intestinal major surgery; no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metocloperamide, cisaperide, difenoxilate, opium and non-steroidal anti-inflammatory drugs; no pregnancy and lactation; not athlete or bed rest; no history of breast cancer in herself or her family; no severe psychosis
Exclusion criteria: use of soy isoflavones or vitamin D one year before the study; use of soy milk or soy nuts during study; diet changes during study; use of artificial sweetener 2 days before study; no desire to complete the study; adverse effect of supplement; pregnancy during study
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Outcomes (pain, flatulence, diarrhea, constipation ). Timepoint: before and after the 6 weeks. Method of measurement: IBS validated Module according to ROME-III criteria.
- Secondary Outcome Measures
Name Time Method Gut permeability. Timepoint: before and after 6 weeks. Method of measurement: The fecal serin protease.;Antioxidant status. Timepoint: before and after 6 weeks. Method of measurement: Serum total antioxidant capacity.;Inflammation status. Timepoint: before and after 6 weeks. Method of measurement: Serum tumor necrosis factor-alpha.