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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Fatty Liver	Dietary Supplement: Resveratrol; Dietary Supplement: Placebo	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	September 2011
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change in hepatic steatosis and inflammation [ Time Frame: 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 Outcome Measures :

1. Assessment of tolerability and side-effects [ Time Frame: 6 months ]
   Assessment of tolerability and side-effects of Resveratrol versus placebo

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Denmark
Aarhus University Hospital, Dept. of Hepatology and Gastroentology
Aarhus, Denmark, 8000

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01464801 History of Changes
Other Study ID Numbers:	LIRMOI 3
First Posted:	November 4, 2011
Last Update Posted:	June 15, 2015
Last Verified:	August 2013

Keywords provided by University of Aarhus:

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Resveratrol; Human study

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Resveratrol; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antimutagenic Agents; Anticarcinogenic Agents