Metabolic SyndromeNCT01150955
Potential Beneficial Effects of Resveratrol
A study testing Resveratrol in people with Metabolic Syndrome and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- 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
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Nov 2011
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 30 kg/m2
- Otherwise healthy
- Written informed consent
Who cannot join
- Any disease
- Alcohol dependency
- Allergy to trial medication
- Present or previous malignancy
- Participation in other clinical trials within three months before randomization
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Endocrinology, MEA
Aarhus, 8000
About this study
Official title: Potential Beneficial Effects of Resveratrol on Obesity, Metabolic Syndrome and Inflammation - Emphasis on Description of the Molecular Biology Underpinning the Interplay Between Calorie Restriction, SIRT1, STAT5 and the GH/IGF-I Axis
We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.
Read the detailed description
The aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. We hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. Of special interest is the potential connection between resveratrol, calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Diabetes, SIRT1, STAT5, IGF-I, Growth hormone, NAFLD, Longevity, Substrate metabolism, Calorie restriction
- Medical subject headings
- Metabolic Syndrome, Obesity, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Also called Fluxome Sciences.
500 mg three times a day for five weeks.
PlaceboOther
Also called Starch
Placebo (starch capsules) 500 mg three times a day for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | Dietary supplement of resveratrol 500 mg three times a day over five weeks. Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic parameters
Regarding glucose, protein and fat metabolism.
Measured: Five weeks
Secondary outcomes (1)
Pathways of substrate metabolism.
Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
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 Metabolic SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 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
- Jens Otto L Jørgensen, Professor,MD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150955
- Sponsor's protocol ID
- M-20100058
- Status last verified
- Mar 2012
- First submitted
- 24 Jun 2010
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Clasen BF, Poulsen MM, Escande C, Pedersen SB, Moller N, Chini EN, Jessen N, Jorgensen JO. Growth hormone signaling in muscle and adipose tissue of obese human subjects: associations with measures of body composition and interaction with resveratrol treatment. J Clin Endocrinol Metab. 2014 Dec;99(12):E2565-73. doi: 10.1210/jc.2014-2215.
PubMed 25050904Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stodkilde-Jorgensen H, Moller N, Jessen N, Pedersen SB, Jorgensen JO. High-dose resveratrol supplementation in obese men: an investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition. Diabetes. 2013 Apr;62(4):1186-95. doi: 10.2337/db12-0975. Epub 2012 Nov 28.
PubMed 23193181
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Beneficial Effects of Resveratrol on Obesity, Metabolic Syndrome and Inflammation - Emphasis on Description of the Molecular Biology Underpinning the Interplay Between Calorie Restriction, SIRT1, STAT5 and the GH/IGF-I Axis
- ClinicalTrials.gov ID
- NCT01150955
- Acronym / sponsor ID
- M-20100058
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Resveratrol, Diabetes, SIRT1, STAT5, IGF-I, Growth hormone, NAFLD, Longevity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Jun 2010 (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.
We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.
Detailed description
The aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. We hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. Of special interest is the potential connection between resveratrol, calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Dietary Supplement: ResveratrolDietary supplement of resveratrol 500 mg three times a day over five weeks. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 30 kg/m2
- Otherwise healthy
- Written informed consent
Key exclusion criteria (5 listed)
- Any disease
- Alcohol dependency
- Allergy to trial medication
- Present or previous malignancy
- Participation in other clinical trials within three months before randomization
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 |
|---|---|---|
| ResveratrolAlso: Fluxome Sciences.500 mg three times a day for five weeks. | Dietary supplement | Resveratrol |
| PlaceboAlso: StarchPlacebo (starch capsules) 500 mg three times a day for five weeks. | Other | Placebo |
Primary outcome
Metabolic parameters
Time frame: Five weeks
Regarding glucose, protein and fat metabolism.
1 secondary outcome
Pathways of substrate metabolism.
Time frame: Five weeks
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 22 Mar 2012.
- Derived from this study: PubMed 25050904Clasen BF, Poulsen MM, Escande C, Pedersen SB, Moller N, Chini EN, Jessen N, Jorgensen JO. Growth hormone signaling in muscle and adipose tissue of obese human subjects: associations with measures of body composition and interaction with resveratrol treatment. J Clin Endocrinol Metab. 2014 Dec;99(12):E2565-73. doi: 10.1210/jc.2014-2215.
- Derived from this study: PubMed 23193181Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stodkilde-Jorgensen H, Moller N, Jessen N, Pedersen SB, Jorgensen JO. High-dose resveratrol supplementation in obese men: an investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition. Diabetes. 2013 Apr;62(4):1186-95. doi: 10.2337/db12-0975. Epub 2012 Nov 28.
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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.
Jens Otto L Jørgensen, Professor,MD study chair
Aarhus University Hospital
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 Metabolic Syndrome and Obesity, 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 3 inclusion and 5 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 22 Mar 2012. 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?
Metabolic parameters (time frame: Five weeks). 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 NCT01150955, 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 22 Mar 2012.