Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)
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ClinicalTrials.gov Identifier: NCT01464801 |
Recruitment Status
:
Completed
First Posted
: November 4, 2011
Last Update Posted
: June 15, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fatty Liver | Dietary Supplement: Resveratrol Dietary Supplement: Placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Resveratrol
Subjects are given resveratrol 500 mg 3 times daily for 6 months.
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Dietary Supplement: Resveratrol
Tablet Resveratrol 500 mg 3 times daily for 6 months
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Placebo Comparator: Placebo
Subjects are given Placebo tablets 3 times daily for 6 months.
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Dietary Supplement: Placebo
Tablet Placebo 3 times daily for 6 months
|
- 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
- Assessment of tolerability and side-effects [ Time Frame: 6 months ]Assessment of tolerability and side-effects of Resveratrol versus placebo

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464801
Denmark | |
Aarhus University Hospital, Dept. of Hepatology and Gastroentology | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Henning Grønbæk, MD, PhD | Department of Hepatology and Gastroentology, Aarhus University Hospital |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01464801 History of Changes |
Other Study ID Numbers: |
LIRMOI 3 |
First Posted: | November 4, 2011 Key Record Dates |
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 |