Fatty Liver
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Resveratrol, Human study
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTResveratrol
Tablet Resveratrol 500 mg 3 times daily for 6 months
DIETARY_SUPPLEMENTPlacebo
Tablet Placebo 3 times daily for 6 months
Sponsors
The Ministry of Science, Technology and Innovation, Denmark
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hepatic steatosis and inflammation | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of tolerability and side-effects | 6 months | Assessment of tolerability and side-effects of Resveratrol versus placebo |
Countries
Denmark
Outcome results
None listed