Clinical trial NCT01464801: Resveratrol in Patients With Non-alcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Keywords: Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Resveratrol
Human study
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Aarhus University Hospital
First posted: 2011-11-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in hepatic steatosis and inflammation
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of tolerability and side-effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Dept. of Hepatology and Gastroentology
Study officials:
affiliation: Department of Hepatology and Gastroentology, Aarhus University Hospital
name: Henning Grønbæk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: