Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
NCT ID: NCT01446276
Last Updated: 2014-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2011-11-30
2014-04-30
Brief Summary
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The investigators hypothesize that resveratrol will:
* decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
* decrease liver fat content
* increase insulin sensitivity
The investigators will look at changes in:
* lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)
* liver fat content (MR liver spectroscopy)
* insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
* body composition (DXA and MRI)
* lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Resveratrol
Resveratrol 500mg 3 times daily for six month
Resveratrol
500 mg 3 times daily for six month
Placebo
Placebo 1 tablet 3 times daily for six month
Placebo
1 placebo tablet 3 times daily for six month
Control group
Men without non-alcoholic fatty liver disease
No interventions assigned to this group
Interventions
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Resveratrol
500 mg 3 times daily for six month
Placebo
1 placebo tablet 3 times daily for six month
Eligibility Criteria
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Inclusion Criteria
* 25-65 years
* Obesity (BMI \> 28 kg/m2, waist/hip ratio \> 0,95)
* Have nonalcoholic fatty liver disease (NAFLD)(intervention group) or do not have NAFLD (control group)
* May have hypertension and/or hypercholesterolemia
* Written informed consent
Exclusion Criteria
* Present and previous malignancy
* Alcohol dependency (more than 21 units of alcohol per week)
* History of smoking
* Participation in studies with radioactive isotopes within the last six months
* Hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men)
25 Years
65 Years
MALE
No
Sponsors
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The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Søren Nielsen, MD, associate professor, DMSc
Role: STUDY_CHAIR
Department of Endocrinology and Internal Medicine
Locations
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Department of Endocrinology and Internal Medicine
Aarhus C, , Denmark
Countries
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References
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Poulsen MK, Nellemann B, Bibby BM, Stodkilde-Jorgensen H, Pedersen SB, Gronbaek H, Nielsen S. No effect of resveratrol on VLDL-TG kinetics and insulin sensitivity in obese men with nonalcoholic fatty liver disease. Diabetes Obes Metab. 2018 Oct;20(10):2504-2509. doi: 10.1111/dom.13409. Epub 2018 Jul 5.
Poulsen MK, Nellemann B, Stodkilde-Jorgensen H, Pedersen SB, Gronbaek H, Nielsen S. Impaired Insulin Suppression of VLDL-Triglyceride Kinetics in Nonalcoholic Fatty Liver Disease. J Clin Endocrinol Metab. 2016 Apr;101(4):1637-46. doi: 10.1210/jc.2015-3476. Epub 2016 Feb 1.
Other Identifiers
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M-20110172A
Identifier Type: -
Identifier Source: org_study_id
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