NCT01126229

Resveratrol for Improved Performance in the Elderly

A Pilot Study of Resveratrol Supplementation for Memory and Physical Performance

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Memory

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	2 capsules of placebo daily for 12 weeks
DRUG	Low dose Resveratrol	2 capsules daily for 12 weeks containing 300 mg/d (combined) of resveratrol active ingredient
DRUG	High dose Resveratrol	2 capsules daily for 12 weeks containing 1000 mg/d (combined) of resveratrol active ingredient

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-05-19
• Last updated: 2013-12-11

Locations

1 site across 1 country: United States