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Flavanol-Rich Cocoa and Cerebral Blood Flow

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ClinicalTrials.gov Identifier: NCT00825695
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : April 30, 2014
Sponsor:
Collaborator:
MasterFoods
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment
Hypertension Diabetes Dietary Supplement: cocoa

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Flavanol-Rich Cocoa, Vascular Responses and Mechanisms
Study Start Date : January 2009
Primary Completion Date : March 2012
Study Completion Date : June 2013

Arm Intervention/treatment
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



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


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

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

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 Posted: January 21, 2009    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014