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

NCT ID: NCT02030977

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

Non Alcoholic Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Resveratrol

Active Comparator: Resveratrol

1 Resveratrol capsules for 12 weeks

Group Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo

one capsule per day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

placebo

Intervention Type: OTHER

Other Intervention Names

Dietary Supplement: Resveratrol; 1 Resveratrol capsule per day for 12 weeks

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Azita Hekmatdoost

OTHER

Sponsor Role: lead

Responsible Party

Dr Azita Hekmatdoost

PI

Responsibility Role: SPONSOR_INVESTIGATOR

References

Faghihzadeh F, Adibi P, Rafiei R, Hekmatdoost A. Resveratrol supplementation improves inflammatory biomarkers in patients with nonalcoholic fatty liver disease. Nutr Res. 2014 Oct;34(10):837-43. doi: 10.1016/j.nutres.2014.09.005. Epub 2014 Sep 23.

Reference Type: DERIVED

PMID: 25311610 (View on PubMed)

Other Identifiers

046468

Identifier Type: -

Identifier Source: org_study_id