HypertensionPhase 4NCT00661986
Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
A Phase 4 study testing dark chocolate 6 g/day and dark chocolate 25 g/day in people with Hypertension, run by University of Leipzig.
Trial summary
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- dark chocolate 6 g/day and dark chocolate 25 g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
- high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
- informed consent
Who cannot join
- habituary intake of dark chocolate or cocoa products
- mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
- pregnancy
- uncontrolled diabetes
- severe comorbidity
- change in blood pressure medication within last 6 weeks
- participation in another trial
About this study
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).
- Conditions
- Hypertension
- Being tested
- dark chocolate 6 g/day, dark chocolate 25 g/day
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dark chocolate 6 g/dayDietary supplement
dark chocolate 6 g/day
dark chocolate 25 g/dayDietary supplement
dark chocolate 25 g/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dark chocolate 6 g/day Receives: Dietary Supplement: dark chocolate 6 g/day |
| 2 | Active comparator | dark chocolate 25 g/day Receives: Dietary Supplement: dark chocolate 25 g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean ambulatory arterial blood pressure
Measured: 3 months
Secondary outcomes (2)
change in weight and BMI
Measured: 3 months
change in various lab parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661986
- Sponsor's protocol ID
- Leipzig chocolate
- Status last verified
- Jan 2010
- First submitted
- 17 Apr 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
- ClinicalTrials.gov ID
- NCT00661986
- Acronym / sponsor ID
- Leipzig chocolate
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Apr 2008 (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.
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: dark chocolate 6 g/daydark chocolate 6 g/day |
| 2 | Active comparator | Dietary Supplement: dark chocolate 25 g/daydark chocolate 25 g/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
- high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
- informed consent
Key exclusion criteria (7 listed)
- habituary intake of dark chocolate or cocoa products
- mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
- pregnancy
- uncontrolled diabetes
- severe comorbidity
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 chocolate 6 g/daydark chocolate 6 g/day | Dietary supplement | 1 |
| dark chocolate 25 g/daydark chocolate 25 g/day | Dietary supplement | 2 |
Primary outcome
change in mean ambulatory arterial blood pressure
Time frame: 3 months
2 secondary outcomes
change in weight and BMI
Time frame: 3 months
change in various lab parameters
Time frame: 3 months
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 2 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dark chocolate 6 g/day and dark chocolate 25 g/day in people with Hypertension, run by University of Leipzig.
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 7 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
change in mean ambulatory arterial blood pressure (time frame: 3 months). 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 2 Feb 2010.