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Resveratrol and Serum Apo A-I

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Dyslipidemia

Treatments

Dietary Supplement: Resveratrol capsules

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01364961
MEC 10-3-054

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

Cellulose capsules
Placebo Comparator group
Treatment:
Dietary Supplement: Resveratrol capsules
Resveratrol capsules
Experimental group
Treatment:
Dietary Supplement: Resveratrol capsules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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