Coronary Artery DiseasePhase 1CocoaNCT00553774
Effect of Cocoa Flavanols on Vascular Function
A Phase 1 study testing Cocoa Flavanols in people with Coronary Artery Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cocoa Flavanols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2008
- Phase
- Phase 1
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAD patients over 18 years of age
- Contact university for more details.
Who cannot join
- Contact university for more details.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
Official title: Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation
Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.
- Conditions
- Coronary Artery Disease
- Being tested
- Cocoa Flavanols, Placebo
- Keywords
- CAD Patients on Optimal Treatment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa FlavanolsDietary supplement
Cocoa Flavanols (BD for 21 - 28 days)
PlaceboOther
Placebo (BD 21 - 28 Days)
| Study group | Role | What they receive |
|---|---|---|
| Flavanol | Experimental | Cocoa Flavanol Receives: Dietary Supplement: Cocoa Flavanols |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
An improvement of endothelial function as measured by flow-mediated dilation (FMD)
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 posted6 Nov 2007 (estimated)
- Study startMar 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Yerem Yeghiazarians, University of California, San Francisco
- Investigators
- Yerem Yeghiazarians, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553774
- Sponsor's protocol ID
- CHR#H47369-28112
- Acronym
- Cocoa
- Status last verified
- Oct 2016
- First submitted
- 2 Nov 2007
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Heiss C, Jahn S, Taylor M, Real WM, Angeli FS, Wong ML, Amabile N, Prasad M, Rassaf T, Ottaviani JI, Mihardja S, Keen CL, Springer ML, Boyle A, Grossman W, Glantz SA, Schroeter H, Yeghiazarians Y. Improvement of endothelial function with dietary flavanols is associated with mobilization of circulating angiogenic cells in patients with coronary artery disease. J Am Coll Cardiol. 2010 Jul 13;56(3):218-24. doi: 10.1016/j.jacc.2010.03.039.
PubMed 20620742
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation
- ClinicalTrials.gov ID
- NCT00553774
- Acronym / sponsor ID
- Cocoa / CHR#H47369-28112
- Conditions
- Coronary Artery Disease
- Keywords
- CAD Patients on Optimal Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Mar 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Nov 2007 (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.
Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavanol | Experimental | Dietary Supplement: Cocoa FlavanolsCocoa Flavanol |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CAD patients over 18 years of age
- Contact university for more details.
Key exclusion criteria (1 listed)
- Contact university for more details.
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 |
|---|---|---|
| Cocoa FlavanolsCocoa Flavanols (BD for 21 - 28 days) | Dietary supplement | Flavanol |
| PlaceboPlacebo (BD 21 - 28 Days) | Other | Placebo |
Primary outcome
An improvement of endothelial function as measured by flow-mediated dilation (FMD)
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 27 Oct 2016.
- Derived from this study: PubMed 20620742Heiss C, Jahn S, Taylor M, Real WM, Angeli FS, Wong ML, Amabile N, Prasad M, Rassaf T, Ottaviani JI, Mihardja S, Keen CL, Springer ML, Boyle A, Grossman W, Glantz SA, Schroeter H, Yeghiazarians Y. Improvement of endothelial function with dietary flavanols is associated with mobilization of circulating angiogenic cells in patients with coronary artery disease. J Am Coll Cardiol. 2010 Jul 13;56(3):218-24. doi: 10.1016/j.jacc.2010.03.039.
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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.
Yerem Yeghiazarians, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cocoa Flavanols in people with Coronary Artery Disease, run by University of California, San Francisco 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 2 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 27 Oct 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
An improvement of endothelial function as measured by flow-mediated dilation (FMD) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553774, which also lists 1 linked publication.
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 27 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.