NCT00639665

Brief Summary

Observing how cocoa effects the cardiovascular and renal system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

3.4 years

First QC Date

March 14, 2008

Last Update Submit

March 30, 2015

Conditions

Diabetes

Keywords

Cocoa, diabetes, polyphenols

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic Measurements

    Hourly measurements (5-6 hours total)

Secondary Outcomes (1)

  • Blood Pressure

    Hourly (5-6 hours)

Interventions

CocoaOTHER

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic (Type I and II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole red blood cells will be retained for DNA analysis. Subjects may "opt-out" of genetic testing.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Norman K Hollenberg, M.D., Ph.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Ebrahim Barkouadh, M.D., M.P.H.

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Physiologic Research

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

US(1)