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Flavanol-Rich Cocoa and Cerebral Blood Flow

NCT ID: NCT00825695

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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flavanol-rich cocoa

Group Type ACTIVE_COMPARATOR

cocoa

Intervention Type DIETARY_SUPPLEMENT

two servings of cocoa daily for one month

flavanol-poor cocoa

Group Type PLACEBO_COMPARATOR

cocoa

Intervention Type DIETARY_SUPPLEMENT

two servings of cocoa daily for one month

Interventions

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cocoa

two servings of cocoa daily for one month

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cocoa Pro

Eligibility Criteria

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Inclusion Criteria

* diabetes and/or hypertension

Exclusion Criteria

* alzheimers disease, dementia, stroke, recent angina or heart attack
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MasterFoods

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Naomi DL Fisher, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naomi D. Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HL089570

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P-001936

Identifier Type: -

Identifier Source: org_study_id