Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Information provided by:
Brigham and Women's Hospital Identifier:
First received: March 14, 2008
Last updated: December 22, 2009
Last verified: December 2009

Observing how cocoa effects the cardiovascular and renal system.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Resource links provided by NLM:

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

Biospecimen Retention:   Samples With DNA

Whole red blood cells will be retained for DNA analysis. Subjects may "opt-out" of genetic testing.

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population



Inclusion Criteria:


Exclusion Criteria:


  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 identifier: NCT00639665

United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Norman K Hollenberg, M.D., Ph.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Norman K. Hollenberg, M.D., Ph.D., Brigham & Women's Hospital Identifier: NCT00639665     History of Changes
Other Study ID Numbers: 2000P-002347
Study First Received: March 14, 2008
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Cocoa, diabetes, polyphenols processed this record on March 03, 2015