Cardiovascular Health of Older Adults and Resveratrol (CORE)

NCT02909699 | Completed DMC

• 1 other identifier: IRB201601756
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (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.

  Change from Baseline and 3 months

Secondary Outcomes (7)

• Flow-mediated dilation

  Change from baseline and 3 months

• Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)

  Baseline and 3 months

• Endothelin-1 protein expression will be measured by Western Blot

  Change from baseline and 3 months

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

  Change from baseline and 3 months

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

  Change from baseline and 3 months

Study Arms (3)

Dose 1

1,000mg of resveratrol per day (1 pill 3 times per day). This ancillary study will be observational without drug administration.

Other: Observation

Dose 2

1,500mg of resveratrol per day (1 pill 3 times per day)

Other: Observation

Placebo

Alike looking 1 pill 3 times per day

Other: Observation

Interventions

Observation OTHER

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

Dose 1; Dose 2; Placebo

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderately functioning older adults.

You may qualify if:

• 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:

• 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;

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Robert T Mankowski, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)