Cardiovascular Health of Older Adults and Resveratrol (CORE)

Completed · Has a placebo group

Conditions studied: Aging

In brief

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.

Key facts

Study ID

NCT02909699

Run by

University of Florida

People needed

27

Starts

2016-11-01

Expected to finish

2018-03-31

Last updated by the study team

2018-11-29

Who can join

Age: 65 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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