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

This study has been completed.
Sponsor:
Collaborator:
MasterFoods
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00639665
First received: March 14, 2008
Last updated: March 30, 2015
Last verified: March 2015

March 14, 2008
March 30, 2015
January 2008
June 2011   (final data collection date for primary outcome measure)
Hemodynamic Measurements [ Time Frame: Hourly measurements (5-6 hours total) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00639665 on ClinicalTrials.gov Archive Site
Blood Pressure [ Time Frame: Hourly (5-6 hours) ] [ Designated as safety issue: No ]
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 (Type I and II)
Diabetes
Other: Cocoa
Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure <165/105

Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication

Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639665
2000P-002347
No
Not Provided
Not Provided
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
MasterFoods
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
Brigham and Women's Hospital
March 2015

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