NCT01446276

Brief Summary

The purpose of this study is to investigate potential metabolic effects of resveratrol in obese healthy men with non-alcoholic fatty liver disease. 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 28, 2014

Status Verified

October 1, 2013

Enrollment Period

2.4 years

First QC Date

October 3, 2011

Last Update Submit

April 25, 2014

Conditions

ObesityNonalcoholic Fatty Liver Disease

Keywords

ObesityResveratrolNonalcoholic fatty liver diseaseInsulin sensitivityLipid turnoverLiver fat content

Outcome Measures

Primary Outcomes (1)

  • Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance

    \- Changes from baseline after treatment with either resveratrol or placebo

    six month

Secondary Outcomes (5)

  • Basal and insulin stimulated free fatty acid (FFA) and glucose turnover

    six month

  • VLDL-TG oxidation

    six month

  • Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)

    six month

  • lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy

    six months

  • Baseline data

    Baseline

Study Arms (3)

Resveratrol

EXPERIMENTAL

Resveratrol 500mg 3 times daily for six month

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet 3 times daily for six month

Other: Placebo

Control group

NO INTERVENTION

Men without non-alcoholic fatty liver disease

Interventions

ResveratrolDIETARY_SUPPLEMENT

500 mg 3 times daily for six month

Resveratrol
PlaceboOTHER

1 placebo tablet 3 times daily for six month

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • 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

You may not qualify if:

  • Any other disease than NAFLD (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus C, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 29885082DERIVED

  • 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.

    PMID: 26829441DERIVED

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver DiseaseInsulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Søren Nielsen, MD, associate professor, DMSc

    Department of Endocrinology and Internal Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 28, 2014

Record last verified: 2013-10

Locations

DK(1)