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Cardiovascular Health of Older Adults and Resveratrol (CORE)

Cardiovascular Health of Older Adults and Resveratrol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02909699
Acronym
CORE
Enrollment
27
Registered
2016-09-21
Start date
2016-11-30
Completion date
2018-03-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Brief summary

This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts) can improve heart muscle function and ability of arteries to dilate in response to an increase in blood flow in adults 65 years of age and older. Additionally, investigators will look at how resveratrol can improve functioning of cells (cellular house-keeping) which can be related to cardiovascular function.

Detailed description

Age-related declines in left ventricular function and endothelium-dependent vasodilation increase the risk for cardiovascular (CV) disease and premature death in older adults. Structural changes to the arterial wall and cardiac muscle are indicated as a cause and appear to be induced by age-related oxidative stress and inflammation and reduced levels of autophagy, the cellular house-keeping system. Pre-clinical studies indicate that resveratrol (RSV), a polyphenol present mostly in grapes and red wine, may improve left ventricular cardiac muscle and endothelial vasodilator function. Although, RSV has been shown to induce autophagy and improve CV function in animals, evidence for its effects on the CV system in humans is lacking, and there is a need for clinical trials to better understand the effects of RSV on CV function in humans. Because older adults are most likely to have impairments in the central and peripheral CV systems, they represent an ideal population to test the effects of RSV on CV function. Therefore, the central hypothesis is that RSV supplementation will improve age-related left ventricular cardiac muscle function and arterial vasodilation in older adults (\> 65 years). The participants will undergo 90 days of RSV treatment (n=12) (1,000mg/day), or (n=12) (1,500mg/day) or placebo (n=12). Before and after the intervention, investigators will non-invasively investigate left ventricular and arterial vasodilator function. Additionally, investigators will examine cardiac muscle damage and inflammatory biomarkers in blood and autophagy and endothelial function protein levels and in skeletal muscle to better understand molecular mechanisms that may underlie the hypothesized beneficial effects of RSV on cardiovascular health in older adults.

Interventions

OTHERObservation

In this trial, cardiovascular function will be measured without drug administration. The drug will be administered within the main trial.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

All the criteria are the same as in the parent R01 (IRB201400439). Participants must meet all inclusion criteria listed below in order to participate in this study. * Ability to understand study procedures and to comply with them for the entire length of the study; * Age 65 years and older; * Moderately functioning (i.e. a summary score of 4 - 12 on the Short Physical Performance Battery); * Body Mass Index (BMI) range: 20-39.9 kg/m2; * Willingness to undergo all testing procedures.

Exclusion criteria

All candidates meeting any of the

Design outcomes

Primary

MeasureTime frameDescription
Speckle tracking analysesChange from Baseline and 3 monthsSpeckle tracking analyses will be performed using advanced quantification software version. Short axis and long axis images will be automatically divided into six segments. Automated tracking of myocardial speckles will be reviewed and manually adjusted as minimally as possible. The tracking quality of each segment will be visually evaluated and if tracking is felt to be inaccurate, strain analysis of that segment will not be included. Speckle tracking analysis provides peak and time to peak measures of circumferential, radial and longitudinal strain and strain rate in 18 left ventricle (LV) segments.

Secondary

MeasureTime frameDescription
Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)Baseline and 3 monthsAutophagy will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
Endothelin-1 protein expression will be measured by Western BlotChange from baseline and 3 monthsEndothelin-1 protein expression will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Western BlotChange from baseline and 3 monthsEndothelial function endothelial nitric oxide synthase will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
Flow-mediated dilationChange from baseline and 3 monthsA duplex ultrasound image of the brachial artery (i.e., 2-D image and spectral Doppler waveforms) will be obtained ∼7 cm proximal to the antecubital fossa.
Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Enzyme-linked immunosorbent assay (ELISA)Change from baseline and 3 monthsEndothelial function endothelial nitric oxide synthase will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
Autophagy measured by Western BlotChange from Baseline and 3 monthsAutophagy will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
Endothelin-1 protein expression will be measured by Enzyme-linked immunosorbent assay (ELISA)Change from baseline and 3 monthsEndothelin-1 protein expression will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026