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

NCT02030977 | Completed Phase 2

• 1 other identifier: 046468
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Alaninaminotransferase(ALT)

  12 weeks

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

one capsule per day

Other: placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Also known as: Dietary Supplement: Resveratrol, 1 Resveratrol capsule per day for 12 weeks

Resveratrol

placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Weight loss more than 10% of baseline body weight during the intervention period.
• Pregnancy;
• Disliking to continue the study.

Sponsors & Collaborators

• Dr Azita Hekmatdoost: lead

Related Publications (1)

• 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.

  PMID: 25311610 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: January 9, 2014
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01