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 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|
- Hemodynamic Measurements [ Time Frame: Hourly measurements (5-6 hours total) ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: Hourly (5-6 hours) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole red blood cells will be retained for DNA analysis. Subjects may "opt-out" of genetic testing.
|Study Start Date:||January 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639665
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Norman K Hollenberg, M.D., Ph.D.||Brigham and Women's Hospital|
|Study Director:||Ebrahim Barkouadh, M.D., M.P.H.||Brigham and Women's Hospital|