Resveratrol for Improved Performance in the Elderly
| Status: | Archived |
|---|---|
| Conditions: | Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
Phase 2a Pilot Study of Resveratrol Supplementation for Memory and Physical Performance
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.
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.
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