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CompletedNCT00825695Updated Apr 30, 2014

Flavanol-Rich Cocoa and Cerebral Blood Flow

An interventional study of cocoa in Hypertension and Diabetes, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2014-04-30.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hypertension
  • Diabetes

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diabetes and/or hypertension

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    flavanol-rich cocoa

    Dietary Supplement: cocoa

  • Placebo comparator
    flavanol-poor cocoa

    Dietary Supplement: cocoa

Interventions

  • Dietary supplementcocoa

    two servings of cocoa daily for one month

    Also known as: Cocoa Pro

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What researchers measure

Primary outcomes

  1. functional transcranial doppler measures

    Time frame: 1 month

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Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00825695
Lead sponsor
Brigham and Women's Hospital
Collaborators
MasterFoods
Responsible party
Naomi DL Fisher, MD (Principal Investigator, Brigham and Women's Hospital) — Principal investigator
First posted
Jan 21, 2009
Start date
Jan 2009
Primary completion
Mar 2012
Completion
Jun 2013
Last update
Apr 30, 2014

Study contacts

Naomi D. Fisher, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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