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Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI).
The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI.
Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.
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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) (UL) | by biochemical method | 28 weeks |
| hepatic steatosis (cap score) | using transient elastography | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) (kg/m2) | using formula | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azita Hakmatdost, MD, PhD | Contact | 9123065084 | a_hekmat2000@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NNFTRI clinic | Recruiting | Tehran | Tehran Province | 19435 | Iran |
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| Placebo |
| Dietary Supplement |
2 placebo capsules per day for 28 weeks |
|
| 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 |
| D010829 | Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |
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