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Flavanol-Rich Cocoa and Cerebral Blood Flow

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825695
First Posted: January 21, 2009
Last Update Posted: April 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MasterFoods
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital
  Purpose
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
Hypertension Diabetes Dietary Supplement: cocoa

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

Further study details as provided by Naomi DL Fisher, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • functional transcranial doppler measures [ Time Frame: 1 month ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes and/or hypertension

Exclusion Criteria:

  • alzheimers disease, dementia, stroke, recent angina or heart attack
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825695


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
MasterFoods
Investigators
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
ClinicalTrials.gov Identifier: NCT00825695     History of Changes
Other Study ID Numbers: P-001936
1R01HL089570 ( U.S. NIH Grant/Contract )
First Submitted: January 20, 2009
First Posted: January 21, 2009
Last Update Posted: April 30, 2014
Last Verified: April 2014