Resveratrol and Serum Apo A-I

NCT01364961 | Completed

• 1 other identifier: MEC 10-3-054
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ApoA-I level

  Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (4)

• Endothelial function and arterial stiffness

  Measured in weeks 4 and 12

• Endothelial function of the retinal microvasculature

  Measured in weeks 4 and 12

• Lipid and glucose metabolism during the fasting and postprandial phase

  Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

• biomarkers for low-grade systemic inflammation and endothelial function

  Measured at baseline, after 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Cellulose capsules

PLACEBO COMPARATOR

Dietary Supplement: Resveratrol capsules

Resveratrol capsules

EXPERIMENTAL

Dietary Supplement: Resveratrol capsules

Interventions

Resveratrol capsules DIETARY_SUPPLEMENT

2 x 75 mg resveratrol each day, for 4 weeks

Also known as: Resveratrol will be provided as resVida®

Cellulose capsules; Resveratrol capsules

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25790328 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Ronald P Mensink, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: June 3, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

NL (1)