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OpenTrials
Completed

NCT Number: NCT01364961

Resveratrol and Serum Apo A-I

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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Resveratrol capsules

Dietary Supplement

2 x 75 mg resveratrol each day, for 4 weeks

Other names: Resveratrol will be provided as resVida®

Primary outcomes

  1. ApoA-I level

    Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Secondary outcomes

  1. Endothelial function and arterial stiffness

    Time frame: Measured in weeks 4 and 12

  2. Endothelial function of the retinal microvasculature

    Time frame: Measured in weeks 4 and 12

  3. Lipid and glucose metabolism during the fasting and postprandial phase

    Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

  4. biomarkers for low-grade systemic inflammation and endothelial function

    Time frame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 3, 2011
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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