ObesityLIRMOINCT01412645
Long-term Investigation of Resveratrol in Obesity
A study testing Resveratrol in people with Obesity and Inflammation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to investigate potential metabolic effects of resveratrol in men with metabolic syndrome(otherwise healthy). The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation, Insulin Sensitivity
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Aug 2013
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 30-60 years old
- Metabolic Syndrome
- Written informed consent
Who cannot join
- Diabetes, thyroid or parathyroid disease, hypogonadism
- Treatment-requiring osteoporosis
- Heart, liver or kidney disease
- Present or previous malignancy
- MR contraindication
- Alcohol dependency
- Weight > 130 kilograms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
The aim of this study is to investigate potential metabolic effects of resveratrol in men with metabolic syndrome(otherwise healthy).
The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate bone-turnover.
Read the detailed description
The study will be done in a collaboration between two PhD students, who focus on effects in adipose- and muscle- tissue, and bone tissue respectively.
The investigators will look at changes in
- inflammation-markers
- biochemical markers of fat- and sugar-metabolism
- gene-expression in fat- and muscle-tissue
- body composition (DXA (whole body) and MR spectroscopy)
- biochemical markers of bone-metabolism
- Bone Mineral Density (DXA scans)
- bone structure (QCT)
- gene-expression and cytokines in bone marrow
Some of the volunteers will have their insulin sensitivity measured.
- Conditions
- Obesity, Inflammation, Insulin Sensitivity, Osteoporosis
- Being tested
- Resveratrol
- Keywords
- Obesity, Inflammation, Metabolic Syndrome, Insulin sensitivity, Osteoporosis, Bone turnover, Ectopic fat accumulation, Resveratrol
- Medical subject headings
- Obesity, Inflammation, Insulin Resistance, Osteoporosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or
1 placebo 2 times daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Resveratrol |
| High-dose Resveratrol | Experimental | Not described Receives: Dietary Supplement: Resveratrol |
| Low-dose Resveratrol | Experimental | Not described Receives: Dietary Supplement: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2013
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
- 76 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, Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Steen B Pedersen, MD, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412645
- Sponsor's protocol ID
- LIRMOI
- Acronym
- LIRMOI
- Status last verified
- Dec 2013
- First submitted
- 13 Jul 2011
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kjaer TN, Ornstrup MJ, Poulsen MM, Stodkilde-Jorgensen H, Jessen N, Jorgensen JOL, Richelsen B, Pedersen SB. No Beneficial Effects of Resveratrol on the Metabolic Syndrome: A Randomized Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1642-1651. doi: 10.1210/jc.2016-2160.
PubMed 28182820Ornstrup MJ, Harslof T, Kjaer TN, Langdahl BL, Pedersen SB. Resveratrol increases bone mineral density and bone alkaline phosphatase in obese men: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4720-9. doi: 10.1210/jc.2014-2799.
PubMed 25322274
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
- ClinicalTrials.gov ID
- NCT01412645
- Acronym / sponsor ID
- LIRMOI / LIRMOI
- Conditions
- Obesity, Inflammation, Insulin Sensitivity, Osteoporosis
- Keywords
- Obesity, Inflammation, Metabolic Syndrome, Insulin sensitivity, Osteoporosis, Bone turnover, Ectopic fat accumulation, Resveratrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Central Denmark Region
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Aug 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 aim of this study is to investigate potential metabolic effects of resveratrol in men with metabolic syndrome(otherwise healthy).
The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate bone-turnover.
Detailed description
The study will be done in a collaboration between two PhD students, who focus on effects in adipose- and muscle- tissue, and bone tissue respectively.
The investigators will look at changes in
- inflammation-markers
- biochemical markers of fat- and sugar-metabolism
- gene-expression in fat- and muscle-tissue
- body composition (DXA (whole body) and MR spectroscopy)
- biochemical markers of bone-metabolism
- Bone Mineral Density (DXA scans)
- bone structure (QCT)
- gene-expression and cytokines in bone marrow
Some of the volunteers will have their insulin sensitivity measured.
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 |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Resveratrol |
| High-dose Resveratrol | Experimental | Dietary Supplement: Resveratrol |
| Low-dose Resveratrol | Experimental | Dietary Supplement: Resveratrol |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- 30-60 years old
- Metabolic Syndrome
- Written informed consent
Key exclusion criteria (7 listed)
- Diabetes, thyroid or parathyroid disease, hypogonadism
- Treatment-requiring osteoporosis
- Heart, liver or kidney disease
- Present or previous malignancy
- MR contraindication
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 |
|---|---|---|
| Resveratrol500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or 1 placebo 2 times daily for 4 months | Dietary supplement | High-dose Resveratrol, Low-dose Resveratrol, Placebo |
Primary outcome
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
Time frame: 4 months
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 13 Dec 2013.
- Derived from this study: PubMed 28182820Kjaer TN, Ornstrup MJ, Poulsen MM, Stodkilde-Jorgensen H, Jessen N, Jorgensen JOL, Richelsen B, Pedersen SB. No Beneficial Effects of Resveratrol on the Metabolic Syndrome: A Randomized Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1642-1651. doi: 10.1210/jc.2016-2160.
- Derived from this study: PubMed 25322274Ornstrup MJ, Harslof T, Kjaer TN, Langdahl BL, Pedersen SB. Resveratrol increases bone mineral density and bone alkaline phosphatase in obese men: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4720-9. doi: 10.1210/jc.2014-2799.
- Official web page for the LIRMOI projekt, background 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.
Steen B Pedersen, MD, PhD principal investigator
University of Aarhus
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 Inflammation, 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 4 inclusion and 7 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 13 Dec 2013. 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?
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo (time frame: 4 months). 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 NCT01412645, 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 13 Dec 2013.