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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy isoflavones | Dietary Supplement |
| ||
| cholecalciferol |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Clinics of Tehran University of Medical Sciences | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31677711 | Derived | 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. | |
| 27490103 | Derived |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| Dietary Supplement |
|
|
| Placebo of soy isoflavones | Dietary Supplement |
|
| placebo of cholecalciferol | Dietary Supplement |
|
| 6 weeks |
| 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. |
| 26396720 | 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. |
| D004066 | Digestive System Diseases |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |