ObesityNCT01446276
Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
A study testing Resveratrol in people with Obesity and Nonalcoholic Fatty Liver Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Obesity, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine
Aarhus C, 8000
About this study
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
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)
- Conditions
- Obesity, Nonalcoholic Fatty Liver Disease
- Being tested
- Resveratrol, Placebo
- Keywords
- Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
500 mg 3 times daily for six month
PlaceboOther
1 placebo tablet 3 times daily for six month
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol 500mg 3 times daily for six month Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Placebo 1 tablet 3 times daily for six month Receives: Other: Placebo |
| Control group | No intervention | Men without non-alcoholic fatty liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
- Changes from baseline after treatment with either resveratrol or placebo
Measured: six month
Secondary outcomes (5)
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
- Changes from baseline after treatment with either resveratrol or placebo
Measured: six month
VLDL-TG oxidation
- Changes from baseline after treatment with either resveratrol or placebo
Measured: six month
Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
- Changes from baseline after treatment with either resveratrol or placebo
Measured: six month
lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
- Changes from baseline after treatment with either resveratrol or placebo
Measured: six months
Baseline data
- Comparison of baseline data between intervention group and control group
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Sponsor
- Investigators
- Søren Nielsen, MD, associate professor, DMSc, Study chair, Department of Endocrinology and Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446276
- Sponsor's protocol ID
- M-20110172A
- Status last verified
- Oct 2013
- First submitted
- 3 Oct 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29885082Poulsen 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.
PubMed 26829441
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01446276
- Acronym / sponsor ID
- M-20110172A
- Conditions
- Obesity, Nonalcoholic Fatty Liver Disease
- Keywords
- Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolResveratrol 500mg 3 times daily for six month |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 1 tablet 3 times daily for six month |
| Control group | No intervention | –Men without non-alcoholic fatty liver disease |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resveratrol500 mg 3 times daily for six month | Dietary supplement | Resveratrol |
| Placebo1 placebo tablet 3 times daily for six month | Other | Placebo |
Primary outcome
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
Time frame: six month
- Changes from baseline after treatment with either resveratrol or placebo
5 secondary outcomes
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
Time frame: six month
VLDL-TG oxidation
Time frame: six month
Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
Time frame: six month
lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
Time frame: six months
Baseline data
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Derived from this study: PubMed 29885082Poulsen 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.
- Derived from this study: PubMed 26829441Poulsen 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.
- Official web page for the LIRMOI (Long-term Investigation of Resveratrol, Metabolism, Obesity and Inflammation) project, back ground info and contactLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Nielsen, MD, associate professor, DMSc study chair
Department of Endocrinology and Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Obesity and Nonalcoholic Fatty Liver Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.