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AgingCORENCT02909699

Cardiovascular Health of Older Adults and Resveratrol (CORE)

An observational study of Aging, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Observation
Type of treatment
Pill or oral medicine
How many people
27 participants
Where
1 siteUnited States
Study dates
Nov 2016to 31 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Moderately functioning older adults.

Who may be able to join

  • 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.

Who cannot join

  • All candidates meeting any of the exclusion criteria listed below at baseline will be disqualified from study participation.
  • Non-English speaking individual.
  • Failure to provide informed consent;
  • Allergy/sensitivity to grapes or Japanese knotweed;
  • Current dietary supplementation of grape seed extract or ginko biloba;
  • Consumption of ≥ 8 oz. of red wine/dealcoholized red wine/red or purple grape juice more than once weekly;
Show all 33Show fewer
  • Consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum in the previous 90 days;
  • Active treatment for cancer, stroke (< 6 months), peripheral vascular disease, coronary artery disease, myocardial infarction (< 6 months), congestive heart failure (stage III or IV), valvular heart disease, major psychiatric disease, severe anemia (blood levels of Hemoglobin < 8 g/dl), bleeding disorders or other blood disorders, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity ( < 6 months), upper or lower extremity amputation, or Parkinson's disease;
  • Cognitive impairment (i.e. Mini Mental Status Exam ≤ 23 \& Clinical Dementia Rating ≥1);
  • History of significant head injury;
  • Physical activity (i.e. running, bicycling, etc.) ≥ 150 min/week;
  • Excessive alcohol use (> 2 drinks/day) or alcohol abuse (> 5 drinks/day for males, or > 4 drinks/day for females);
  • History of substance abuse within the past six months;
  • Mood disorder (i.e. Center for Epidemiological Studies - Depression (CES-D) ≥ 16);
  • History of tobacco use within the past three years;
  • Resting heart rate > 120 bpm at screening visit;
  • Systolic blood pressure > 160 mm Hg at screening visit;
  • Diastolic blood pressure > 90 mm Hg at screening visit;
  • Fasting glucose ≥ 126 mg/dL at screening visit;
  • Abnormalities in blood chemistry parameters, defined by blood chemistry marker outside of healthy range) as determined by study physician
  • Current use of
  • anabolic treatments (e.g. growth hormone or testosterone),
  • anticholinesterase inhibitor (e.g. Aricept),
  • hormone replacement (e.g. Estrogen),
  • anticoagulant therapies (note: aspirin -anti-platelet use (≤ 81mg/day) is permitted) or
  • use of anti-inflammatory medications more than 3 times per week.;
  • Participation in another non-observational clinical trial, or has received an investigational product within 30 days prior to screening/enrollment;
  • Refuse to refrain from CoQ10 or alpha-lipoic acid while enrolled in the study.
  • Temporary Exclusion Criteria
  • A person meeting any of the following temporary exclusion criteria at the time of screening would not be enrolled but may be re-screened at a later date. A period of 4 weeks is the minimum amount of time required before re-screening for the following conditions can be done.
  • Recent bacterial/viral infection (< 2 weeks);
  • Acute febrile illness in past 2 months;
  • High blood pressure (i.e. ≥ 140/90 mm Hg but ≤ 160/90) at the screening visit; Major surgery or hip/knee replacement (< 6 months);

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Cardiovascular Health of Older Adults and Resveratrol

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.

Read the 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.

Conditions
Aging
Being tested
Observation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

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

Study groups in NCT02909699
Study groupRoleWhat they receive
Dose 11,000mg of resveratrol per day (1 pill 3 times per day). This ancillary study will be observational without drug administration.
Receives: Other: Observation
Dose 21,500mg of resveratrol per day (1 pill 3 times per day)
Receives: Other: Observation
PlaceboAlike looking 1 pill 3 times per day
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speckle tracking analyses

    Speckle 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.

    Measured: Change from Baseline and 3 months

Secondary outcomes (7)

  1. Flow-mediated dilation

    A 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.

    Measured: Change from baseline and 3 months

  2. Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)

    Autophagy will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.

    Measured: Baseline and 3 months

  3. Endothelin-1 protein expression will be measured by Western Blot

    Endothelin-1 protein expression will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.

    Measured: Change from baseline and 3 months

  4. Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Western Blot

    Endothelial function endothelial nitric oxide synthase will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.

    Measured: Change from baseline and 3 months

  5. Endothelin-1 protein expression will be measured by Enzyme-linked immunosorbent assay (ELISA)

    Endothelin-1 protein expression will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.

    Measured: Change from baseline and 3 months

  6. Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Enzyme-linked immunosorbent assay (ELISA)

    Endothelial 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.

    Measured: Change from baseline and 3 months

  7. Autophagy measured by Western Blot

    Autophagy will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.

    Measured: Change from Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909699
Sponsor's protocol ID
IRB201601756
Acronym
CORE
Status last verified
Nov 2018
First submitted
13 Sep 2016
Last updated
29 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aging, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speckle tracking analyses (time frame: Change from Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

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