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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639665
First Posted: March 20, 2008
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MasterFoods
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
  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

Further study details as provided by Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Hemodynamic Measurements [ Time Frame: Hourly measurements (5-6 hours total) ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Hourly (5-6 hours) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 14, 2008
First Posted: March 20, 2008
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital:
Cocoa, diabetes, polyphenols

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