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

NCT02026518 | Completed Phase 4 DMC

• 1 other identifier: 459
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Irritable Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (4)

Soy

EXPERIMENTAL

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

Soy- Cholecalciferol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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; Dietary Supplement: placebo of cholecalciferol

Cholecalciferol

EXPERIMENTAL

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; Dietary Supplement: Placebo of soy isoflavones

Interventions

Soy isoflavones DIETARY_SUPPLEMENT

Soy; Soy- Cholecalciferol

cholecalciferol DIETARY_SUPPLEMENT

Also known as: Vitamin D

Cholecalciferol; Soy- Cholecalciferol

Placebo of soy isoflavones DIETARY_SUPPLEMENT

Cholecalciferol; Placebo

placebo of cholecalciferol DIETARY_SUPPLEMENT

Placebo; Soy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Gastrointestinal Clinics of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Related Publications (3)

• 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.

  PMID: 31677711 DERIVED

• 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.

  PMID: 27490103 DERIVED

• 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.

  PMID: 26396720 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Soybean Proteins; Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 3, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

IR (1)