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| Name | Class |
|---|---|
| The Ministry of Science, Technology and Innovation, Denmark | OTHER_GOV |
| Aarhus University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Subjects are given resveratrol 500 mg 3 times daily for 6 months. |
|
| Placebo | Placebo Comparator | Subjects are given Placebo tablets 3 times daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | Tablet Resveratrol 500 mg 3 times daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic steatosis and inflammation | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tolerability and side-effects | Assessment of tolerability and side-effects of Resveratrol versus placebo | 6 months |
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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:
BMI ≥ 25 kg/m²
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Grønbæk, MD, PhD | Department of Hepatology and Gastroentology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Dept. of Hepatology and Gastroentology | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo |
| Dietary Supplement |
Tablet Placebo 3 times daily for 6 months |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |