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
  Purpose

Observing how cocoa effects the cardiovascular and renal system.


Condition Intervention
Diabetes
Other: Cocoa

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:

Primary Outcome Measures:
  • Hemodynamic Measurements [ Time Frame: Hourly measurements (5-6 hours total) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 228
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

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

Diabetic (Type I and II)

Criteria

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

  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: NCT00639665

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
MasterFoods
Investigators
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
  More Information

No publications provided

Responsible Party: Norman K. Hollenberg, MD, PhD, Director Physiologic Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00639665     History of Changes
Other Study ID Numbers: 2000P-002347
Study First Received: March 14, 2008
Last Updated: March 30, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Cocoa, diabetes, polyphenols

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 02, 2015