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To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Active Comparator | 2 synbiotic capsules for 28 weeks |
|
| maltodexterin | Placebo Comparator | two capsules per day for 28 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| synbiotic | Dietary Supplement | 2 symbiotics capsules per day for 28 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Alaninaminotransferase (ALT) | 28 weeks | |
| Liver fibrosis | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azita Hekmatdoost, MD, PhD | National Nutrition and Food Technology Research Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24401715 | Derived | Eslamparast T, Poustchi H, Zamani F, Sharafkhah M, Malekzadeh R, Hekmatdoost A. Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study. Am J Clin Nutr. 2014 Mar;99(3):535-42. doi: 10.3945/ajcn.113.068890. Epub 2014 Jan 8. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| placebo |
| Other |
2 Maltodexterin capsules as a placebo per day for 28 weeks |
|
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |