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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Disease
• Intervention / Treatment: Dietary supplement: Soy isoflavones; Dietary supplement: placebo of cholecalciferol; Dietary supplement: cholecalciferol; Dietary supplement: Placebo of soy isoflavones

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Gastrointestinal Clinics of Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. age 18-75 yrs
2. patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria
3. BMI 18-25
4. a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery
5. no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs
6. no pregnancy and lactation
7. not athlete or bed rest
8. no history of breast cancer in herself or her family
9. no severe psychosis

Exclusion Criteria:

1. a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study
2. diet changes during study
3. use of artificial sweetener 2 days before study
4. no desire to complete the study
5. adverse effect of supplement
6. pregnancy during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soy; 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; Dietary supplement: placebo of cholecalciferol
Experimental: Soy- Cholecalciferol; 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; Dietary supplement: cholecalciferol; Other Names: Vitamin D
Placebo Comparator: Placebo; 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 cholecalciferol; Dietary supplement: Placebo of soy isoflavones
Experimental: Cholecalciferol; 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; Other Names: Vitamin D; Dietary supplement: Placebo of soy isoflavones

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Jalili M, Vahedi H, Poustchi H, Hekmatdoost A. Soy isoflavones and cholecalciferol reduce inflammation, and gut permeability, without any effect on antioxidant capacity in irritable bowel syndrome: A randomized clinical trial. Clin Nutr ESPEN. 2019 Dec;34:50-54. doi: 10.1016/j.clnesp.2019.09.003. Epub 2019 Oct 2.
• Jalili M, Hekmatdoost A, Vahedi H, Poustchi H, Khademi B, Saadi M, Zemestani M, Janani L. Co-Administration of Soy Isoflavones and Vitamin D in Management of Irritable Bowel Disease. PLoS One. 2016 Aug 4;11(8):e0158545. doi: 10.1371/journal.pone.0158545. eCollection 2016.
• Jalili M, Vahedi H, Janani L, Poustchi H, Malekzadeh R, Hekmatdoost A. Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial. Middle East J Dig Dis. 2015 Jul;7:170-6.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 26, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 459