The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Phase 2

Completed

• Conditions: Non Alcoholic Fatty Liver
• Interventions: Dietary Supplement: Resveratrol; Other: placebo

• Registration Number: NCT02030977
• Lead Sponsor: Dr Azita Hekmatdoost

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Study First Submitted: 2013-12-29
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks
Placebo	placebo	one capsule per day

Primary Outcome Measures

Name	Time	Method
Alaninaminotransferase(ALT)	12 weeks