Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)
This study has been completed.
Sponsor:
University of Aarhus
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01464801
First received: September 29, 2011
Last updated: June 12, 2015
Last verified: August 2013
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Purpose
Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in the Western world and strongly associated with obesity. No known effective treatment is known. From animal studies, it is known that the compound resveratrol perhaps has the potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of Resveratrol on fatty liver disease. The researchers plan to investigate the effects of Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.
| Condition | Intervention |
|---|---|
|
Fatty Liver |
Dietary Supplement: Resveratrol Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds, Study 3 |
Resource links provided by NLM:
MedlinePlus related topics:
Liver Diseases
Drug Information available for:
Resveratrol
U.S. FDA Resources
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Change in hepatic steatosis and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]Changes in hepatic and inflammatory markers ind the blood such as ALT, hs-CRP, TNFa Changes in hepatic fat content, assessed by MR spectroscopy Changes in hepatic steatosis and inflammation, assessed histologically Changes in the expression of proteins in the relevant inflammatory pathways, assessed by gene expression studies
Secondary Outcome Measures:
- Assessment of tolerability and side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Assessment of tolerability and side-effects of Resveratrol versus placebo
| Enrollment: | 28 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Resveratrol
Subjects are given resveratrol 500 mg 3 times daily for 6 months.
|
Dietary Supplement: Resveratrol
Tablet Resveratrol 500 mg 3 times daily for 6 months
|
|
Placebo Comparator: Placebo
Subjects are given Placebo tablets 3 times daily for 6 months.
|
Dietary Supplement: Placebo
Tablet Placebo 3 times daily for 6 months
|
Detailed Description:
Obesity is associated with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH) and recently, low-grade inflammation has been hypothesized to be the causative link. From animal studies, it is known that the compound resveratrol (RES) has strong anti-inflammatory and antioxidant effects and perhaps the potential to neutralize obesity-induced diseases. RES is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of RES on fatty liver disease. In a double-blind controlled clinical trial, the researchers investigate the effects of RES 500 mg or placebo treatment x 3 daily for 6 months on NAFLD/NASH in 48 obese patients in a double-blind, randomised, controlled clinical trial. The researchers hypothesize that RES improves the ALT levels and reduces liver fat and inflammation assessed by MR spectroscopy and histological evaluation.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ALT ≥70 U/L for men and ≥45 U/L for women
- steatosis of the liver, assessed by ultrasonography
-
one of the following:
- waist circumference ≥102 cm for men and ≥88 for women
- hypertension: BP ≥130/80 mmHg
- raised triglycerides ≥1,7 mmol/L
- reduced HDL cholesterol ≤1.0 mmol/L
- BMI ≥ 25 kg/m²
Exclusion Criteria:
- weight > 130 kg
- comorbidity such as diabetes, cancer, metabolic or coagulation disorder, or significant liver-, heart- or kidney disease
- MRI contraindication
- treatment with glucocorticoids or methotrexate
- alcohol intake >20g/daily for men and >12 for women
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464801
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464801
Locations
| Denmark | |
| Aarhus University Hospital, Dept. of Hepatology and Gastroentology | |
| Aarhus, Denmark, 8000 | |
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Aarhus University Hospital
Investigators
| Principal Investigator: | Henning Grønbæk, MD, PhD | Department of Hepatology and Gastroentology, Aarhus University Hospital |
More Information
Additional Information:
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01464801 History of Changes |
| Other Study ID Numbers: | LIRMOI 3 |
| Study First Received: | September 29, 2011 |
| Last Updated: | June 12, 2015 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Resveratrol Human study |
Additional relevant MeSH terms:
|
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease 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 |
ClinicalTrials.gov processed this record on September 28, 2016