Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
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ALT ≥70 U/L for men and ≥45 U/L for women
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steatosis of the liver, assessed by ultrasonography
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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
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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