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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030977
• Other study ID #: 046468
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 29, 2013
• Last updated: January 7, 2014
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAN: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Fatty Liver

Intervention

Dietary Supplement:
• Resveratrol

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr Azita Hekmatdoost

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alaninaminotransferase(ALT)		12 weeks	Yes