The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effects of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Conditions
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Non Alcoholic Steatohepatitis

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: hesperidin and flaxseed
* Dietary Supplement: Dietary Supplement: hesperidin
* Dietary Supplement: Dietary Supplement: flaxseed
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 to 70 years Body Mass Index (BMI) between 25-40 Sonographic findings compatible with hepatic steatosis (degree 2 or more) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hesperidin and flaxseed<br> | Dietary Supplement: Dietary Supplement: hesperidin and flaxseed<br>* 2 capsules hesperidin and 30 g flaxseed<br>|
| Placebo Comparator: control<br> | Other: control<br>* no supplementation<br>|
| Active Comparator: flaxseed<br> | Dietary Supplement: Dietary Supplement: flaxseed<br>* 30 g flaxseed<br>|
| Active Comparator: hesperidin<br> | Dietary Supplement: Dietary Supplement: hesperidin<br>* 2 capsules hesperidin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fibrosis | assess by fibroscan | 12 weeks |