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

Mass General Brigham

Status: Completed

Conditions: Diabetes

Treatments: Other: Cocoa

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00639665

2000P-002347

Details and patient eligibility

About

Observing how cocoa effects the cardiovascular and renal system.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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