HypertensionPhase 4NCT01314924
Effects of Acute Ingestion of Dark Chocolate on Endothelial Function in Hypertensive Patients
A Phase 4 study testing Dark chocolate in people with Hypertension, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Dark chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of hypertension
- Use of one or two antihypertensive drugs
- Systolic blood pressure between 130 and 160 mmHg
- Diastolic blood pressure between 85 and 100 mmHg
Who cannot join
- Secondary hypertension
- Diabetes mellitus
- Body mass index > 35kg/m2
- Chronic kidney disease
- Known coronary artery disease
- Previous stroke
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551-030
About this study
Official title: Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate
We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function.
Read the detailed description
Recent findings indicate an inverse relationship between cardiovascular disease and consumption of flavonoids. We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function. Twenty-one hypertensive patients in drug therapy, both genders, aged 40-65 years, were included in a prospective study with measurement of blood pressure, brachial flow-mediated dilatation (FMD), peripheral arterial tonometry (EndoPAT) and central hemodynamic parameters by SphygmoCor. After seven days of eating dark chocolate (70% cocoa) 75g/day, the clinical and vascular evaluation were repeated. Patients were divided into two groups according to the response in FMD: responders (increase in FMD, n=12) and non-responders (no improvement in FMD, n=9).
- Conditions
- Hypertension
- Being tested
- Dark chocolate
- Keywords
- Hypertension, Endothelial dysfunction, Vascular stiffness, Use of one or two antihypertensive drugs
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolateDietary supplement
Also called Cocoa
70% cocoa
| Study group | Role | What they receive |
|---|---|---|
| Responders | Experimental | Patients who present an increase in flow-mediated dilation of brachial artery. Receives: Dietary Supplement: Dark chocolate |
| Non responders | Experimental | Patients who do not present an increase in flow-mediated dilation of brachial artery. Receives: Dietary Supplement: Dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery
Measured: One week
Secondary outcomes (2)
Blood pressure
Systolic and diastolic blood pressure levels evaluated by an automatic device
Measured: One week
Central hemodynamic parameters
Aortic systolic blood pressure and pulse pressure evaluated by SphygmoCor. Vascular stiffness parameters such as augmentation pressure and augmentation index will also be evaluated.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionSep 2011
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
- Investigators
- Jenifer d"El-Rei, MSc, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314924
- Sponsor's protocol ID
- CHOC-70
- Status last verified
- Jan 2012
- First submitted
- 14 Mar 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate
- ClinicalTrials.gov ID
- NCT01314924
- Acronym / sponsor ID
- CHOC-70
- Conditions
- Hypertension
- Keywords
- Hypertension, Endothelial dysfunction, Vascular stiffness, Use of one or two antihypertensive drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Mar 2011 (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.
We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function.
Detailed description
Recent findings indicate an inverse relationship between cardiovascular disease and consumption of flavonoids. We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function. Twenty-one hypertensive patients in drug therapy, both genders, aged 40-65 years, were included in a prospective study with measurement of blood pressure, brachial flow-mediated dilatation (FMD), peripheral arterial tonometry (EndoPAT) and central hemodynamic parameters by SphygmoCor. After seven days of eating dark chocolate (70% cocoa) 75g/day, the clinical and vascular evaluation were repeated. Patients were divided into two groups according to the response in FMD: responders (increase in FMD, n=12) and non-responders (no improvement in FMD, n=9).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | Experimental | Dietary Supplement: Dark chocolatePatients who present an increase in flow-mediated dilation of brachial artery. |
| Non responders | Experimental | Dietary Supplement: Dark chocolatePatients who do not present an increase in flow-mediated dilation of brachial artery. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous diagnosis of hypertension
- Use of one or two antihypertensive drugs
- Systolic blood pressure between 130 and 160 mmHg
- Diastolic blood pressure between 85 and 100 mmHg
Key exclusion criteria (6 listed)
- Secondary hypertension
- Diabetes mellitus
- Body mass index > 35kg/m2
- Chronic kidney disease
- Known coronary artery disease
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 |
|---|---|---|
| Dark chocolateAlso: Cocoa70% cocoa | Dietary supplement | Non responders, Responders |
Primary outcome
Endothelial function
Time frame: One week
Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery
2 secondary outcomes
Blood pressure
Time frame: One week
Central hemodynamic parameters
Time frame: One week
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 11 Jan 2012.
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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.
Jenifer d"El-Rei, MSc principal investigator
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dark chocolate in people with Hypertension, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 4 inclusion and 6 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 11 Jan 2012. 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 Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Endothelial function (time frame: One week). 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 11 Jan 2012.