HypertensionPhase 1NCT00654862
Acute Hemodynamic Effects of Cocoa Polyphenols in Subjects With Hypertension and Optimal Blood Pressure
A Phase 1 study testing cocoa polyphenols in people with Hypertension, run by University of Cologne at 1 site in Germany.
Trial summary
Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increasing the formation of vasodilative nitric oxide. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- cocoa polyphenols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Sep 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unpaid volunteers of both sex between 50 and 75 years of age in good general health.
- Diagnosis of stage 1 essential hypertension (BP between 140/90 and 160/100 mmHg) or optimal BP below 120/80) and stable BP values.
- No antihypertensive medications or nutritional supplements.
- Non-manual workers or pensioners of higher socioeconomic status (household income of more than 20,000 €/year)
- Leisure physical activity of less than 7 METs per week
- Normal levels of plasma lipids and plasma glucose.
Who cannot join
- Cardiovascular diseases (other than hypertension).
- Diabetes mellitus.
- Hyper-/dyslipidemia.
- Gastrointestinal diseases
- Hepatic and renal disorders
- Pulmonary diseases.
Show all 24Show fewer
- Coagulopathy.
- Cancer.
- Psychiatric disorders.
- Alcohol or drug dependence.
- Seizure disorders.
- History of organ transplantation.
- Surgery within the last 12 months.
- Positive tests for HIV, hepatitis B or C.
- Body-mass index of more than 27.5 or less than 18.5 kg/m2
- Active smokers of tobacco within the last five years.
- Regular users of medications.
- Use of any medication within the last two weeks before entry.
- Users of vitamin, mineral or polyphenol supplements or other bioactive food supplements.
- Regular consumers of chocolate or other cocoa products of more than 1 serving per week.
- Subjects will be excluded if they are unable to give informed consent for all procedures. Subjects who are not capable or willing to attend to all interventions will be withdrawn.
- Subjects will be withdrawn if the allocation concealment is disclosed.
- Subjects will be withdrawn if any adverse events requiring further monitoring or medical treatment occur.
- A systolic BP >170 mmHg or <100 mmHg or a diastolic BP >110 mmHg or <50 mmHg at a single determination will result in immediate withdrawal of the participant from the study and the appropriate treatment will be resumed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pharmacology, University of Cologne
Cologne, D-50931
About this study
Official title: Randomized Controlled, Double-Blind, Sample Size-Calculated, Three-Period Crossover, Phase 1 Study to Investigate the Efficacy of a Single Oral Dose of Cocoa Phenols on Blood, Pressure, Heart Rate and Plasma Levels of Phenols, Bioactive Nitric Oxide and Oxidation Markers in Subjects With Stage 1 Essential Hypertension and Optimal Blood Pressure
Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increasing the formation of vasodilative nitric oxide. However, direct evidence for this assumption from controlled clinical studies is lacking. Moreover, in hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction and vascular smooth muscle remodeling, but it is unclear whether the BP response to cocoa phenols differs between subjects with high blood pressure and optimal blood pressure.
The investigators hypothesized that (1) intake of cocoa phenols cause a dose-dependent, acute elevation of circulating bioactive NO levels and a reduction in BP, and that (2) the NO elevation and BP reduction are impaired in patients with hypertension.
To test this hypothesis, the investigators will conduct a prospective, randomized, placebo-controlled, double-blind, sample size-calculated, three-period crossover study with pre-planned statistical analysis and trial monitoring, in which cocoa phenols will be orally administered to subjects with mild essential hypertension or subjects with optimal blood pressure. The effects on blood pressure, heart rate, arterial function and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress will be evaluated. After a 7-day cocoa-free run-in period and a 12-hour overnight fast, 48 subjects (24 with hypertension and 24 sex-, and age (+/- 2yrs)-matched subjects with optimal blood pressure) will receive either a single dose of 1000 mg cocoa polyphenols, 250 mg cocoa phenols or placebo (in capsules of equal form and weight). Each intervention will be followed by a 7-day cocoa-free washout period before cross-over to the subsequent intervention. Subjects will be allocated to the intervention sequence by permuted block randomization (i.e. permuted blocks of 2 subjects with high BP and 2 subjects with optimal BP each, are assigned to permutations of the tree interventions). Measurements of hemodynamic and plasma parameters will be performed directly before and 30, 60, 90, 120, 180, 300, and 480 min after capsule administration. Included subjects will be counseled to maintain their usual diet and physical activity and to abstain from all cocoa products during the study. Analysis of the data will be performed on an intention-to-treat basis.
- Conditions
- Hypertension
- Being tested
- cocoa polyphenols
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocoa polyphenolsDietary supplement
Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
cocoa polyphenolsDietary supplement
Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects with stage 1 hypertension Receives: Dietary Supplement: cocoa polyphenols |
| 2 | Experimental | Subjects with optimal blood pressure Receives: Dietary Supplement: cocoa polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Measured: Assessments at 3 time points
Secondary outcomes (1)
Changes in plasma levels of bioactive nitric oxide, arterial function, oxidation markers and cocoa polyphenols
Measured: Assessments at 3 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Dirk Taubert, MD, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654862
- Sponsor's protocol ID
- ECA-02-006
- Status last verified
- Feb 2009
- First submitted
- 3 Apr 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Taubert D, Roesen R, Lehmann C, Jung N, Schomig E. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide: a randomized controlled trial. JAMA. 2007 Jul 4;298(1):49-60. doi: 10.1001/jama.298.1.49.
PubMed 17609490Taubert D, Berkels R, Roesen R, Klaus W. Chocolate and blood pressure in elderly individuals with isolated systolic hypertension. JAMA. 2003 Aug 27;290(8):1029-30. doi: 10.1001/jama.290.8.1029. No abstract available.
PubMed 12941673
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Double-Blind, Sample Size-Calculated, Three-Period Crossover, Phase 1 Study to Investigate the Efficacy of a Single Oral Dose of Cocoa Phenols on Blood, Pressure, Heart Rate and Plasma Levels of Phenols, Bioactive Nitric Oxide and Oxidation Markers in Subjects With Stage 1 Essential Hypertension and Optimal Blood Pressure
- ClinicalTrials.gov ID
- NCT00654862
- Acronym / sponsor ID
- ECA-02-006
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 9 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.
Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increasing the formation of vasodilative nitric oxide. However, direct evidence for this assumption from controlled clinical studies is lacking. Moreover, in hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction and vascular smooth muscle remodeling, but it is unclear whether the BP response to cocoa phenols differs between subjects with high blood pressure and optimal blood pressure.
The investigators hypothesized that (1) intake of cocoa phenols cause a dose-dependent, acute elevation of circulating bioactive NO levels and a reduction in BP, and that (2) the NO elevation and BP reduction are impaired in patients with hypertension.
To test this hypothesis, the investigators will conduct a prospective, randomized, placebo-controlled, double-blind, sample size-calculated, three-period crossover study with pre-planned statistical analysis and trial monitoring, in which cocoa phenols will be orally administered to subjects with mild essential hypertension or subjects with optimal blood pressure. The effects on blood pressure, heart rate, arterial function and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress will be evaluated. After a 7-day cocoa-free run-in period and a 12-hour overnight fast, 48 subjects (24 with hypertension and 24 sex-, and age (+/- 2yrs)-matched subjects with optimal blood pressure) will receive either a single dose of 1000 mg cocoa polyphenols, 250 mg cocoa phenols or placebo (in capsules of equal form and weight). Each intervention will be followed by a 7-day cocoa-free washout period before cross-over to the subsequent intervention. Subjects will be allocated to the intervention sequence by permuted block randomization (i.e. permuted blocks of 2 subjects with high BP and 2 subjects with optimal BP each, are assigned to permutations of the tree interventions). Measurements of hemodynamic and plasma parameters will be performed directly before and 30, 60, 90, 120, 180, 300, and 480 min after capsule administration. Included subjects will be counseled to maintain their usual diet and physical activity and to abstain from all cocoa products during the study. Analysis of the data will be performed on an intention-to-treat basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: cocoa polyphenolsSubjects with stage 1 hypertension |
| 2 | Experimental | Dietary Supplement: cocoa polyphenolsSubjects with optimal blood pressure |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unpaid volunteers of both sex between 50 and 75 years of age in good general health.
- Diagnosis of stage 1 essential hypertension (BP between 140/90 and 160/100 mmHg) or optimal BP below 120/80) and stable BP values.
- No antihypertensive medications or nutritional supplements.
- Non-manual workers or pensioners of higher socioeconomic status (household income of more than 20,000 €/year)
- Leisure physical activity of less than 7 METs per week
Key exclusion criteria (24 listed)
- Cardiovascular diseases (other than hypertension).
- Diabetes mellitus.
- Hyper-/dyslipidemia.
- Gastrointestinal diseases
- Hepatic and renal disorders
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 polyphenolsOral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo | Dietary supplement | 1 |
| cocoa polyphenolsOral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo | Dietary supplement | 2 |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: Assessments at 3 time points
1 secondary outcome
Changes in plasma levels of bioactive nitric oxide, arterial function, oxidation markers and cocoa polyphenols
Time frame: Assessments at 3 time points
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 18 Feb 2009.
- Background: PubMed 17609490Taubert D, Roesen R, Lehmann C, Jung N, Schomig E. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide: a randomized controlled trial. JAMA. 2007 Jul 4;298(1):49-60. doi: 10.1001/jama.298.1.49.
- Background: PubMed 12941673Taubert D, Berkels R, Roesen R, Klaus W. Chocolate and blood pressure in elderly individuals with isolated systolic hypertension. JAMA. 2003 Aug 27;290(8):1029-30. doi: 10.1001/jama.290.8.1029. No abstract available.
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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.
Dirk Taubert, MD, PhD principal investigator
University of Cologne
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 polyphenols in people with Hypertension, run by University of Cologne at 1 site in Germany.
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 6 inclusion and 24 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 18 Feb 2009. 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 Germany. 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 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?
Change in systolic and diastolic blood pressure (time frame: Assessments at 3 time points). 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 NCT00654862, which also lists 2 linked publications.
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 18 Feb 2009.