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To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hesperidin and flaxseed | Active Comparator |
| |
| control | Placebo Comparator |
| |
| flaxseed | Active Comparator |
| |
| hesperidin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: hesperidin and flaxseed | Dietary Supplement | 2 capsules hesperidin and 30 g flaxseed |
|
| Measure | Description | Time Frame |
|---|---|---|
| liver fibrosis | assess by fibroscan | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes Taking any kind of antibiotics two weeks before recruitment History of alcohol consumption pregnancy or lactation Professional athletes Other liver disease (viral/etc) Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty Following program to lose weight in recent 3 mo A history of hypothyroidism or Cushing's syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| azita Hekmatdoost, MD.PhD | Contact | +982122357484 | a_hekmat2000@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Recruiting | Tehran | Iran (the Islamic Republic Of) | 1981619573 | Iran |
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| Dietary Supplement: hesperidin | Dietary Supplement | 2 capsules hesperidin |
|
| Dietary Supplement: flaxseed | Dietary Supplement | 30 g flaxseed |
|
| control | Other | no supplementation |
|
| 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 |
|---|---|
| D008043 | Linseed Oil |
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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