DIETARY COCOA FLAVANOLS AND AGE-RELATED MEMORY DECLINE
ClinicalTrials.gov Identifier: NCT02312310
Principal Investigators: Scott A. Small, M.D., Richard P. Sloan, Ph.D.
In a small study, we found that consuming a diet rich in cocoa flavanols (750 mg per day) for three months improved imaging and cognitive measures of memory. However, the sample size of this study was small and replication is required. The aim of this current study to provide that replication. We propose to confirm and extend the finding that a dietary flavanol intake improves age-related memory decline. We are recruiting 200 subjects, age 50-75 years, who meet study inclusion and exclusion criteria. Subjects will be screened by phone and then in person to ensure they meet inclusion criteria. They will complete a medical history questionnaire, a claustrophobia questionnaire, and will be screened for conditions that contra-indicate MRI studies. The Dementia Rating Scale also will be administered before final eligibility is determined. Subjects will be randomized to one of four groups, the members of which will be assigned a specific daily cocoa flavanol intake amount (0mg, 375mg, 500mg or 750mg per day), respectively. Subjects will take the cocoa flavanols for 12 weeks during which they will complete neuropsychological testing at week 4 and at week 8 of the 12-week period. After the 12 weeks, subjects will return for follow-up assessment of MRI and neuropsychological testing. Four weeks after the last cocoa flavanol intake, subjects will complete a final neuropsychological testing.