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
Sponsor:
Collaborator:
MasterFoods
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00639665
First received: March 14, 2008
Last updated: December 22, 2009
Last verified: December 2009

March 14, 2008
December 22, 2009
January 2008
January 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00639665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Observing how cocoa effects the cardiovascular and renal system.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

Diabetic

Diabetes
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Diabetic

Exclusion Criteria:

-

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639665
2000P-002347
No
Norman K. Hollenberg, M.D., Ph.D., Brigham & Women's Hospital
Brigham and Women's Hospital
MasterFoods
Principal Investigator: Norman K Hollenberg, M.D., Ph.D. Brigham and Women's Hospital
Brigham and Women's Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP