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Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease

Primary Purpose

Obesity, Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male
  • 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:

  • 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)

Sites / Locations

  • Department of Endocrinology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Resveratrol

Placebo

Control group

Arm Description

Resveratrol 500mg 3 times daily for six month

Placebo 1 tablet 3 times daily for six month

Men without non-alcoholic fatty liver disease

Outcomes

Primary Outcome Measures

Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
- Changes from baseline after treatment with either resveratrol or placebo

Secondary Outcome Measures

Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
- Changes from baseline after treatment with either resveratrol or placebo
VLDL-TG oxidation
- Changes from baseline after treatment with either resveratrol or placebo
Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
- Changes from baseline after treatment with either resveratrol or placebo
lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
- Changes from baseline after treatment with either resveratrol or placebo
Baseline data
- Comparison of baseline data between intervention group and control group

Full Information

First Posted
October 3, 2011
Last Updated
April 25, 2014
Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01446276
Brief Title
Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
Official Title
Long-term Investigation of Resveratrol on Lipid Turnover in Obese Men With Nonalcoholic Fatty Liver Disease. Effects on Liver Fat Content and Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Nonalcoholic Fatty Liver Disease
Keywords
Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
Resveratrol 500mg 3 times daily for six month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet 3 times daily for six month
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Men without non-alcoholic fatty liver disease
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
500 mg 3 times daily for six month
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 placebo tablet 3 times daily for six month
Primary Outcome Measure Information:
Title
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
Description
- Changes from baseline after treatment with either resveratrol or placebo
Time Frame
six month
Secondary Outcome Measure Information:
Title
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
Description
- Changes from baseline after treatment with either resveratrol or placebo
Time Frame
six month
Title
VLDL-TG oxidation
Description
- Changes from baseline after treatment with either resveratrol or placebo
Time Frame
six month
Title
Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
Description
- Changes from baseline after treatment with either resveratrol or placebo
Time Frame
six month
Title
lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
Description
- Changes from baseline after treatment with either resveratrol or placebo
Time Frame
six months
Title
Baseline data
Description
- Comparison of baseline data between intervention group and control group
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male 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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Nielsen, MD, associate professor, DMSc
Organizational Affiliation
Department of Endocrinology and Internal Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology and Internal Medicine
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29885082
Citation
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.
Results Reference
derived
PubMed Identifier
26829441
Citation
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.
Results Reference
derived

Learn more about this trial

Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease

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