DyslipidemiaNCT01364961
Resveratrol and Serum Apo A-I
A study testing Resveratrol capsules in people with Dyslipidemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Resveratrol capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 45 and 70 years
- HDL-C <1.0 mmol/L (men)
- HDL-C <1.3 mmol/L (women)
- serum total cholesterol <8.0 mmol/L
- plasma glucose <7.0 mmol/L
- BMI between 25 - 35 kg/m2
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- non-smoking
- willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:
- grapes and grape juice
- wine (red and white)
- all berries
- peanuts
- peanut butter
- soy (products)
- pomegranate
Who cannot join
- unstable body weight (weight gain or loss >3 kg in the past 3 months)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
- Active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
- not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
- men: consumption of >21 glasses of alcohol-containing drinks per week women: consumption of >14 glasses of alcohol-containing drinks per week
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- abuse of drugs
- pregnant or breastfeeding women
- participation in another biomedical study within 1 month prior to the screening visit
- having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
- impossible or difficult to puncture as evidenced during the screening visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed.
Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
- Conditions
- Dyslipidemia
- Being tested
- Resveratrol capsules
- Keywords
- Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol capsulesDietary supplement
Also called Resveratrol will be provided as resVida®
2 x 75 mg resveratrol each day, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cellulose capsules | Placebo comparator | Not described Receives: Dietary Supplement: Resveratrol capsules |
| Resveratrol capsules | Experimental | Not described Receives: Dietary Supplement: Resveratrol capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
ApoA-I level
Measured: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
Secondary outcomes (4)
Endothelial function and arterial stiffness
Measured: Measured in weeks 4 and 12
Endothelial function of the retinal microvasculature
Measured: Measured in weeks 4 and 12
Lipid and glucose metabolism during the fasting and postprandial phase
Measured: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
biomarkers for low-grade systemic inflammation and endothelial function
Measured: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionAug 2013
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 DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364961
- Sponsor's protocol ID
- MEC 10-3-054
- Status last verified
- Nov 2013
- First submitted
- 17 Jan 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Made SM, Plat J, Mensink RP. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial. PLoS One. 2015 Mar 19;10(3):e0118393. doi: 10.1371/journal.pone.0118393. eCollection 2015.
PubMed 25790328
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations
- ClinicalTrials.gov ID
- NCT01364961
- Acronym / sponsor ID
- MEC 10-3-054
- Conditions
- Dyslipidemia
- Keywords
- Resveratrol, FMD, PWV, HDL-cholesterol, Macrovasculature, Microvasculature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Jun 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.
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed.
Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellulose capsules | Placebo comparator | Dietary Supplement: Resveratrol capsules |
| Resveratrol capsules | Experimental | Dietary Supplement: Resveratrol capsules |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- aged between 45 and 70 years
- HDL-C <1.0 mmol/L (men)
- HDL-C <1.3 mmol/L (women)
- serum total cholesterol <8.0 mmol/L
- plasma glucose <7.0 mmol/L
Key exclusion criteria (11 listed)
- unstable body weight (weight gain or loss >3 kg in the past 3 months)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
- Active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
- not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
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 |
|---|---|---|
| Resveratrol capsulesAlso: Resveratrol will be provided as resVida®2 x 75 mg resveratrol each day, for 4 weeks | Dietary supplement | Cellulose capsules, Resveratrol capsules |
Primary outcome
ApoA-I level
Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
4 secondary outcomes
Endothelial function and arterial stiffness
Time frame: Measured in weeks 4 and 12
Endothelial function of the retinal microvasculature
Time frame: Measured in weeks 4 and 12
Lipid and glucose metabolism during the fasting and postprandial phase
Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
biomarkers for low-grade systemic inflammation and endothelial function
Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 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 13 Nov 2013.
- Derived from this study: PubMed 25790328van der Made SM, Plat J, Mensink RP. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial. PLoS One. 2015 Mar 19;10(3):e0118393. doi: 10.1371/journal.pone.0118393. eCollection 2015.
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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.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
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 capsules in people with Dyslipidemia, 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 15 inclusion and 11 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 Nov 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 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?
ApoA-I level (time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 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 NCT01364961, 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 13 Nov 2013.