Resveratrol for Improved Performance in the Elderly
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.
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.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Conditions
Memory
Intervention
Placebo, Resveratrol, Resveratrol
Location
University of Florida, Aging and Geriatric Research
Gainesville
Florida
United States
32611
Status
Recruiting
Source
University of Florida
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01126229
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:35-0400
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Medical and Biotech [MESH] Definitions
Memory, Episodic
Type of declarative memory, consisting of personal memory in contrast to general knowledge.
Wechsler Memory Scale
A neuropsychological test designed to assess different memory functions. It may incorporate an optional cognitive exam (Brief Cognitive Status Exam) that helps to assess memory related cognitive function.
Memory Consolidation
Neurological process involving the conversion of learned information into long-term memory.
Memory
Complex mental function having four distinct phases: (1) memorizing or learning, (2) retention, (3) recall, and (4) recognition. Clinically, it is usually subdivided into immediate, recent, and remote memory.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
