Resveratrol and Serum Apo A-I

NCT ID: NCT01364961

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-08-31

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.

Conditions

Dyslipidemia

Keywords

Resveratrol; FMD; PWV; HDL-cholesterol; Macrovasculature; Microvasculature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Cellulose capsules

Group Type: PLACEBO_COMPARATOR

Resveratrol capsules

Intervention Type: DIETARY_SUPPLEMENT

2 x 75 mg resveratrol each day, for 4 weeks

Resveratrol capsules

Group Type: EXPERIMENTAL

Resveratrol capsules

Intervention Type: DIETARY_SUPPLEMENT

2 x 75 mg resveratrol each day, for 4 weeks

Interventions

Resveratrol capsules

2 x 75 mg resveratrol each day, for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Resveratrol will be provided as resVida®

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald P Mensink, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 25790328 (View on PubMed)

Other Identifiers

MEC 10-3-054

Identifier Type: -

Identifier Source: org_study_id