ObesityNCT00998504
resVida and Fat Oxidation
A study testing resVida in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it… Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- resVida
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Jan 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male sex
- age 45-65 years
- body fat percentage > 25%, BMI 30-35 kg/m2
- sedentary
- stable dietary habits
- willingness to abstain from ingestion of resveratrol-containing foods
- healthy
Who cannot join
- female sex
- unstable body weight (weight gain or loss > 3 kg in the last three months)
- total body fat percentage < 25%
- fasting plasma glucose > 6.1 mmol/l
- hemoglobin < 7.8 mmol/l
- engagement in programmed exercise > 2 hours total per week
Show all 20Show fewer
- impaired kidney and/ or liver function
- first- or second-degree family member with type 2 diabetes mellitus
- any medical condition requiring treatment and/ or medication use
- intake of dietary supplements except vitamins and minerals
- unwilling to restrict high-resveratrol containing foods
- current alcohol consumption > 20 grams/day
- participation in another biomedical study within 1 month before the screening visit
- a contraindication to MRI scanning. These contraindications include patients with the following devices:
- central nervous system aneurysm clips
- implanted neural stimulator
- implanted cardiac pacemaker or defibrillator
- cochlear implant
- insulin pump
- or metal containing corpora aliena in the eye or brains
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6200 MD
About this study
Official title: Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects
There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. A major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. Therefore the researchers would like to investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. The researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.
- Conditions
- Obesity
- Being tested
- resVida, placebo
- Keywords
- impaired fat oxidation, fat accumulation, mitochondrial dysfunction, mitochondrial biogenesis
- Medical subject headings
- Obesity, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resVidaDietary supplement
Also called resveratrol
resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.
placeboDietary supplement
resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | starch pill Receives: Dietary Supplement: placebo |
| resVida | Active comparator | synthetic pill containing 75 mg of resveratrol Receives: Dietary Supplement: resVida |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in fat oxidation between resVida and placebo treated group
Measured: 9 months
Secondary outcomes (1)
difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Top Institute Food and Nutrition
- Investigators
- Silvie Timmers, MSc, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998504
- Sponsor's protocol ID
- MEC 09-3-039
- Status last verified
- Mar 2011
- First submitted
- 19 Oct 2009
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Knop FK, Konings E, Timmers S, Schrauwen P, Holst JJ, Blaak EE. Thirty days of resveratrol supplementation does not affect postprandial incretin hormone responses, but suppresses postprandial glucagon in obese subjects. Diabet Med. 2013 Oct;30(10):1214-8. doi: 10.1111/dme.12231. Epub 2013 Jun 7.
PubMed 23663119
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects
- ClinicalTrials.gov ID
- NCT00998504
- Acronym / sponsor ID
- MEC 09-3-039
- Conditions
- Obesity
- Keywords
- impaired fat oxidation, fat accumulation, mitochondrial dysfunction, mitochondrial biogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Top Institute Food and Nutrition
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Oct 2009 (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.
There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. A major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. Therefore the researchers would like to investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. The researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placebostarch pill |
| resVida | Active comparator | Dietary Supplement: resVidasynthetic pill containing 75 mg of resveratrol |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male sex
- age 45-65 years
- body fat percentage > 25%, BMI 30-35 kg/m2
- sedentary
- stable dietary habits
Key exclusion criteria (20 listed)
- female sex
- unstable body weight (weight gain or loss > 3 kg in the last three months)
- total body fat percentage < 25%
- fasting plasma glucose > 6.1 mmol/l
- hemoglobin < 7.8 mmol/l
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 |
|---|---|---|
| resVidaAlso: resveratrolresVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given. | Dietary supplement | resVida |
| placeboresVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given. | Dietary supplement | placebo |
Primary outcome
difference in fat oxidation between resVida and placebo treated group
Time frame: 9 months
1 secondary outcome
difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group
Time frame: 9 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 18 Mar 2011.
- Derived from this study: PubMed 23663119Knop FK, Konings E, Timmers S, Schrauwen P, Holst JJ, Blaak EE. Thirty days of resveratrol supplementation does not affect postprandial incretin hormone responses, but suppresses postprandial glucagon in obese subjects. Diabet Med. 2013 Oct;30(10):1214-8. doi: 10.1111/dme.12231. Epub 2013 Jun 7.
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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.
Silvie Timmers, MSc principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resVida in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 20 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 18 Mar 2011. 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 Netherlands. 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?
difference in fat oxidation between resVida and placebo treated group (time frame: 9 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 NCT00998504, which also lists 1 linked publication.
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 18 Mar 2011.