Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
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: August 15, 2013
Last verified: August 2013
  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:


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


Estimated Enrollment: 48
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464801

Contacts
Contact: Sara Heebøll, MD, PhD stud + 45 27338050 sara.heeboell@ki.au.dk
Contact: Henning Grønbæk, MD, PhD +45 21679281 henning.gronbaek@aarhus.rm.dk

Locations
Denmark
Aarhus University Hospital, Dept. of Hepatology and Gastroentology Recruiting
Aarhus, Denmark, 8000
Contact: Sara Heebøll    27338050    sara.heeboell@ki.au.dk   
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:
No publications provided

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: August 15, 2013
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:
Resveratrol
Fatty Liver
Liver Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014