NCT00825695

Brief Summary

The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable hypertension

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, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

January 20, 2009

Last Update Submit

April 28, 2014

Conditions

HypertensionDiabetes

Outcome Measures

Primary Outcomes (1)

  • functional transcranial doppler measures

    1 month

Study Arms (2)

flavanol-rich cocoa

ACTIVE COMPARATOR
Dietary Supplement: cocoa

flavanol-poor cocoa

PLACEBO COMPARATOR
Dietary Supplement: cocoa

Interventions

cocoaDIETARY_SUPPLEMENT

two servings of cocoa daily for one month

Also known as: Cocoa Pro
flavanol-poor cocoaflavanol-rich cocoa

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • diabetes and/or hypertension

You may not qualify if:

  • alzheimers disease, dementia, stroke, recent angina or heart attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Naomi D. Fisher, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

June 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

US(1)