Trials / Completed
CompletedNCT02312310
Dietary Flavanols and Dentate Gyrus Function
Dietary Cocoa Flavanols and Age-Related Memory Decline
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- New York State Psychiatric Institute · Academic / Other
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin ) on dentate gyrus function and corresponding cognitive function
Detailed description
In this double blinded trial, the participants, age 50-75 years, will be randomized to receive 0, 260, 510, or 770 mg daily\* for 12 weeks and will be tested before and after the intervention. Cognitive testing will be conducted prior to randomization, and at weeks 4, 12, and 20 of the study. In an optional substudy, fMRI (functional magnetic resonance imaging) with gadolinium contrast will be conducted to measure dentate gyrus function before randomization and then after completion of the 12-week intervention portion of the trial. \*see note in Record Log regarding the change in the method of assessment of cocoa flavanol content of the capsules
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Cocoa Flavanol | 12 weeks administration of cocoa flavanol |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2018-11-01
- Completion
- 2020-04-01
- First posted
- 2014-12-09
- Last updated
- 2020-06-11
- Results posted
- 2020-06-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02312310. Inclusion in this directory is not an endorsement.