Non Alcoholic Fatty Liver Clinical Trial
Official title:
The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; 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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 18 and older; - Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography; - No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men; - Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders; - Absence of pregnancy or lactation; - Absence of taking any medications in the past three months; - Absence of weight loss in the recent three months; - Absence of endocrine and metabolism disorders. Exclusion Criteria: - Weight loss more than 10% of baseline body weight during the intervention period. - Pregnancy; - Disliking to continue the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr Azita Hekmatdoost |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alaninaminotransferase(ALT) | 12 weeks | Yes |
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