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

Sponsor
Dr Azita Hekmatdoost (Other)
Overall Status
Completed
CT.gov ID
NCT02030977
Collaborator
(none)
50
Enrollment
2
Arms
9
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Resveratrol
  • Other: placebo
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Resveratrol

Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks

Dietary Supplement: Resveratrol
Other Names:
  • Dietary Supplement: Resveratrol
  • 1 Resveratrol capsule per day for 12 weeks

    		•
    Placebo Comparator: Placebo

    one capsule per day

    Other: placebo

    Outcome Measures

    Primary Outcome Measures

    1. Alaninaminotransferase(ALT) [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Dr Azita Hekmatdoost

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Azita Hekmatdoost, PI, National Nutrition and Food Technology Institute
    ClinicalTrials.gov Identifier:
    NCT02030977
    Other Study ID Numbers:
    • 046468
    First Posted:
    Jan 9, 2014
    Last Update Posted:
    Jan 9, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Resveratrol

    Study Results

    No Results Posted as of Jan 9, 2014