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Flavanol-Rich Cocoa and Cerebral Blood Flow

This study has been completed.
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital Identifier:
First received: January 20, 2009
Last updated: April 28, 2014
Last verified: April 2014
The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.

Condition Intervention
Dietary Supplement: cocoa

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Flavanol-Rich Cocoa, Vascular Responses and Mechanisms

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • functional transcranial doppler measures [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: flavanol-rich cocoa Dietary Supplement: cocoa
two servings of cocoa daily for one month
Other Name: Cocoa Pro
Placebo Comparator: flavanol-poor cocoa Dietary Supplement: cocoa
two servings of cocoa daily for one month
Other Name: Cocoa Pro


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diabetes and/or hypertension

Exclusion Criteria:

  • alzheimers disease, dementia, stroke, recent angina or heart attack
  Contacts and Locations
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Please refer to this study by its identifier: NCT00825695

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Naomi D. Fisher, MD Brigham and Women's Hospital
  More Information

Responsible Party: Naomi DL Fisher, MD, Principal Investigator, Brigham and Women's Hospital Identifier: NCT00825695     History of Changes
Other Study ID Numbers: P-001936  1R01HL089570 
Study First Received: January 20, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board processed this record on October 28, 2016