Flavanol-Rich Cocoa and Cerebral Blood Flow

This study has been completed.
Sponsor:
Collaborator:
MasterFoods
Information provided by (Responsible Party):
Naomi DL Fisher, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00825695
First received: January 20, 2009
Last updated: April 28, 2014
Last verified: April 2014
  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: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Flavanol-Rich Cocoa, Vascular Responses and Mechanisms

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 1RO1HL089570
Study First Received: January 20, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014