Resveratrol for Improved Performance in the Elderly (RIPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01126229
First received: May 17, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The investigators aim to conduct a randomized placebo controlled pilot study to determine whether resveratrol, a dietary ingredient, supplementation is safe and improves memory and physical performance in older adults. Loss in memory and physical performance is a frequent complaint in older adults and a growing public health issue. Additionally, later adulthood is associated with a normative decline in both working and primary memory as well as domains including attention, speed of processing and executive function. Resveratrol is safely tolerated in pre-clinical models and in dose-escalation human studies. It also has demonstrated beneficial effects on memory and performance in pre-clinical models. Therefore, this study will take the next step in understanding the longer-term safety (3 months) and efficacy of resveratrol supplementation on age-related health conditions.


Condition Intervention Phase
Memory
Dietary Supplement: Placebo
Drug: Low dose Resveratrol
Drug: High dose Resveratrol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Pilot Study of Resveratrol Supplementation for Memory and Physical Performance

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Safety Outcomes [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    CBC, Complete Metabolic Panel, Toxicity according to NCI criteria


Secondary Outcome Measures:
  • Cognitive Outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Executive function measured by N-back and Controlled Oral Word Association test, Processing Speed measuring by Trails A & B, Memory Function measured by word recall.

  • Physical Outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Physical function measured by performance on the 400 meter walk test, physical activity levels as measured by accelerometer.


Enrollment: 32
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dietary Supplement: placebo
Dietary Supplement: Placebo
2 capsules of placebo daily for 12 weeks
Experimental: 300 mg/d Resveratrol
Dietary Supplement: 300 mg/d Resveratrol
Drug: Low dose Resveratrol
2 capsules daily for 12 weeks containing 300 mg/d (combined) of resveratrol active ingredient
Other Name: ReserveAge
Experimental: 1000 mg/d Resveratrol
Dietary Supplement: 1000 mg/d Resveratrol
Drug: High dose Resveratrol
2 capsules daily for 12 weeks containing 1000 mg/d (combined) of resveratrol active ingredient
Other Name: ReserveAge

Detailed Description:

Enrolled participants will complete psychological questionnaires and a multi-measure cognitive test battery, physical function, as well as provide blood samples, to determine blood chemistry. These will include complete blood count and complete metabolic count [(Na, K, Cl, CO2, BUN, Creatinine, Glucose, Total Protein, Albumin, Calcium, Phosphorous, Aspartate Aminotransferase (AST), Alkaline Phos, Total Bilirubin, and Alanine Amino Transferase (ALT)] and any others deemed necessary by the study physician. They will return to the laboratory to perform a muscular endurance test and MRI evaluation at the Brain Institute. Eligible participants will be randomly assigned with equal probability to either receive resveratrol (300 mg/d or 1000 mg/d) or placebo for twelve weeks. Immediately following completion of the MRI, participants will be given a month's supply of resveratrol or placebo. All participants will be closely monitored for safety and toxicity during the first 10 days (range 8-12 days are acceptable) of the trial. During this initial evaluation period, blood chemistries (complete metabolic profiles) will be evaluated every 3 (range 1-2 days are acceptable) days. Following one month, participants will be asked to return to clinic. At their monthly visits, memory tests, blood samples will be collected to monitor cognitive adaptations and ensure that no adverse changes have occurred. Participants' compliance with the supplementation regimen will also be checked through pill counts, and participants will be given a month's supply of product at each of their monthly visits. After 12 weeks of taking either resveratrol or a placebo on a daily basis, participants will complete a final test battery, an MRI scan, a blood draw collection. A follow-up evaluation will be provided at 10 and 30 days following completion of the final post-treatment assessment.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 65-100 years
  • Body mass index > = 25 and < = 35
  • Willing and able to participate in all aspects of the study
  • Willing to be randomized to either treatment group
  • Sedentary to moderately active lifestyle (<120 min aerobic activity/week)
  • Report of ability to walk one mile
  • MMSE > 24
  • Non-smoking
  • Telephone Interview for cognitive status (TICS)

Exclusion Criteria:

  • Active treatment for cancer, stroke (< 6 mo), peripheral vascular disease, coronary artery disease (myocardial infarction <6 mo), state III, IV Congestive Heart Failure, valvular heart disease, major psychiatric disease, severe anemia, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity within the last 6 months, upper or lower extremity amputation, anticoagulant therapy (aspirin use is permitted), parkinsons disease
  • Failure to give consent
  • Anabolic medications (growth hormone or testosterone)
  • High amounts of physical activity (i.e. running, bicycling etc) > 120 min/week.
  • Dementing illness
  • Excessive alcohol use (>2 drinks per day)
  • Resting heart rate > 120 bpm
  • Systolic blood pressure > 180 mmHg
  • Diastolic blood pressure > 100 mmHg
  • Dietary supplementation of grape seed extract or ginko biloba
  • History of significant head injury
  • Vision or hearing impairment
  • Anticholinesterase inhibitor (such as Aricept)
  • Contraindications to MRI (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm clip, claustrophobia, etc.)
  • Consumption 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;
  • Subject is participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment
  • Current Use of Antidepressant Medications
  • CES-D Score > 20
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126229

Locations
United States, Florida
University of Florida, Aging and Geriatric Research
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Todd M. Manini, PhD University of Florida, Aging and Geriatric Research
Principal Investigator: Stephen M Manini, PhD University of Florida, Aging and Geriatric Research
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01126229     History of Changes
Other Study ID Numbers: 238-2009
Study First Received: May 17, 2010
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Resveratrol
Grape
Aging
functional MRI (fMRI)
Anti-Aging therapeutic
Oxidative Stress
Functional Performance

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014