Clinical trial NCT01364961: Resveratrol and Serum Apo A-I
Official title: The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Resveratrol
FMD
PWV
HDL-cholesterol
Macrovasculature
Microvasculature
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2011-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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). 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.


Eligibility criteria: 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

Primary outcomes:
measure: ApoA-I level
timeFrame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
measure: Endothelial function and arterial stiffness
timeFrame: Measured in weeks 4 and 12
measure: Endothelial function of the retinal microvasculature
timeFrame: Measured in weeks 4 and 12
measure: Lipid and glucose metabolism during the fasting and postprandial phase
timeFrame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
measure: biomarkers for low-grade systemic inflammation and endothelial function
timeFrame: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.