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

Dr Azita Hekmatdoost

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non Alcoholic Fatty Liver

Treatments: Dietary Supplement: Resveratrol; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02030977

046468

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Resveratrol

Active Comparator group

Description:

Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks

Treatment:

Dietary Supplement: Resveratrol

Placebo

Placebo Comparator group

Description:

one capsule per day

Treatment:

Other: placebo