Clinical Trial: Dietary Flavanols and Dentate Gyrus Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dietary Cocoa Flavanols and Age-Related Memory Decline

Brief Summary: to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin ) on dentate gyrus function and corresponding cognitive function

Detailed Summary:

In this double blinded trial, the participants, age 50-75 years, will be randomized to receive 0, 225, 400, or 650 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 with gadolinium contrast will be conducted to measure dentate gyrus function before randomization and then after completion of the trial.


Sponsor: New York State Psychiatric Institute

Current Primary Outcome: dentate gyrus specific cognitive function [ Time Frame: 20 weeks ]

measured by the modified Benton Recognition Task (ModBent)


Original Primary Outcome:

  • dentate gyrus specific cognitive function [ Time Frame: 12 weeks ]
    measured by the modified Benton Recognition Task (ModBent)
  • dentate gyrus cerebral blood volume [ Time Frame: 12 weeks ]


Current Secondary Outcome:

  • inflammatory markers [ Time Frame: 12 weeks ]
    IL6, CRP, CCL11, TNFa
  • dentate gyrus cerebral blood volume [ Time Frame: 12 weeks ]


Original Secondary Outcome: inflammatory markers [ Time Frame: 12 weeks ]

IL6, CRP, CCL11, TNFa


Information By: New York State Psychiatric Institute

Dates:
Date Received: December 5, 2014
Date Started: December 2015
Date Completion: November 2017
Last Updated: October 11, 2016
Last Verified: October 2016