HypertensionNCT00825695
Flavanol-Rich Cocoa and Cerebral Blood Flow
A study testing cocoa in people with Hypertension and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diabetes and/or hypertension
Who cannot join
- alzheimers disease, dementia, stroke, recent angina or heart attack
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Flavanol-Rich Cocoa, Vascular Responses and Mechanisms
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.
- Conditions
- Hypertension, Diabetes
- Being tested
- cocoa
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocoaDietary supplement
Also called Cocoa Pro
two servings of cocoa daily for one month
| Study group | Role | What they receive |
|---|---|---|
| flavanol-rich cocoa | Active comparator | Not described Receives: Dietary Supplement: cocoa |
| flavanol-poor cocoa | Placebo comparator | Not described Receives: Dietary Supplement: cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional transcranial doppler measures
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MasterFoods
- Responsible party
- Principal investigator, Naomi DL Fisher, MD, Brigham and Women's Hospital
- Investigators
- Naomi D. Fisher, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825695
- Sponsor's protocol ID
- P-001936
- Other IDs
- 1R01HL089570
- Status last verified
- Apr 2014
- First submitted
- 20 Jan 2009
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavanol-Rich Cocoa, Vascular Responses and Mechanisms
- ClinicalTrials.gov ID
- NCT00825695
- Acronym / sponsor ID
- P-001936
- Conditions
- Hypertension, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- MasterFoods
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flavanol-rich cocoa | Active comparator | Dietary Supplement: cocoa |
| flavanol-poor cocoa | Placebo comparator | Dietary Supplement: cocoa |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- diabetes and/or hypertension
Key exclusion criteria (1 listed)
- alzheimers disease, dementia, stroke, recent angina or heart attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cocoaAlso: Cocoa Protwo servings of cocoa daily for one month | Dietary supplement | flavanol-poor cocoa, flavanol-rich cocoa |
Primary outcome
functional transcranial doppler measures
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi D. Fisher, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cocoa in people with Hypertension and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional transcranial doppler measures (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.