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

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ClinicalTrials.gov Identifier: NCT02030977
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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
Non Alcoholic Fatty Liver Dietary Supplement: Resveratrol Other: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013


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



Primary Outcome Measures :
  1. Alaninaminotransferase(ALT) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Azita Hekmatdoost, PI, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02030977     History of Changes
Other Study ID Numbers: 046468
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents