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OpenTrials
Completed

NCT Number: NCT02030977

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

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Dietary Supplement

Other names: Dietary Supplement: Resveratrol, 1 Resveratrol capsule per day for 12 weeks

Placebo

Other

Primary outcomes

  1. Alaninaminotransferase(ALT)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dr Azita Hekmatdoost

Other

Registry information

Official study title

The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2014
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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