Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Fasting blood specimens will be taken from the patients with IBS that have inclusion criteria. First, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. They will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. During 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the other placebo form, both of them and placebo of both. At the end, body mass index ( BMI), serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen receptors will be determined.

Conditions
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Irritable Bowel Disease

Intervention / Treatment
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* Dietary Supplement: Soy isoflavones
* Dietary Supplement: cholecalciferol
* Dietary Supplement: Placebo of soy isoflavones
* Dietary Supplement: placebo of cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 yrs patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria BMI 18-25 a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, 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: a- use of soy isoflavones or vitamin D one year before the study b- 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy<br>Group Soy receiving placebo similar to 50000 IU cholecalciferol (includes MCT oil) biweekly for 6 weeks in addition to 40 milligram (2 capsules per day) soy isoflavones capsules for 6 weeks | Dietary Supplement: Soy isoflavones<br> <br> Dietary Supplement: placebo of cholecalciferol<br> <br> |
| Experimental: Soy- Cholecalciferol<br>Group Soy- Cholecalciferol receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genistein, glycitin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vitamin D3) biweekly for 6 weeks | Dietary Supplement: Soy isoflavones<br> <br> Dietary Supplement: cholecalciferol<br> <br> * Other names: Vitamin D;|
| Placebo Comparator: Placebo<br>Group Placebo receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks | Dietary Supplement: Placebo of soy isoflavones<br> <br> Dietary Supplement: placebo of cholecalciferol<br> <br> |
| Experimental: Cholecalciferol<br>Group Cholecalciferol receiving oral Placebo in similar form to soy isoflavones (diadzein, genistein, glycitin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol supplement biweekly for 6 weeks | Dietary Supplement: cholecalciferol<br> <br> * Other names: Vitamin D;Dietary Supplement: Placebo of soy isoflavones<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline in gut permeability as efficacy at 6 weeks |  | 6 weeks | 
| Change of baseline in antioxidant status as efficacy at 6 weeks |  | 6 weeks | 
| Change of baseline in inflammation status as efficacy at 6 weeks |  | 6 weeks |