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

Primary Purpose

Non Alcoholic Fatty Liver

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Resveratrol
placebo
Sponsored by
Dr Azita Hekmatdoost
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Resveratrol

    Placebo

    Arm Description

    Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks

    one capsule per day

    Outcomes

    Primary Outcome Measures

    Alaninaminotransferase(ALT)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 29, 2013
    Last Updated
    January 7, 2014
    Sponsor
    Dr Azita Hekmatdoost
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02030977
    Brief Title
    The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
    Official Title
    The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Azita Hekmatdoost

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Alcoholic Fatty Liver

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Resveratrol
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    one capsule per day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Resveratrol
    Other Intervention Name(s)
    Dietary Supplement: Resveratrol, 1 Resveratrol capsule per day for 12 weeks
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Alaninaminotransferase(ALT)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25311610
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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