HypertensionNCT00125866
The Effect of Cocoa Flavonoids on Blood Pressure
A study testing Flavonoid rich or flavonoid depleted chocolate drink in people with Hypertension, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Flavonoid rich or flavonoid depleted chocolate drink
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Jan 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or females of any age.
- Diagnosis of hypertension and on antihypertensive treatment.
- Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (<150/90mmHg).
Who cannot join
- Participation in another clinical trial.
- Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
Paddington, London, W2 1PG
About this study
Official title: The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure
The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.
Read the detailed description
Flavonoids are natural substances found in fruits and vegetables, tea and red wine. The investigators know that people who eat a diet rich in these foods are less likely to have heart disease. This, in part, may be due to the blood pressure lowering effect of flavonoids. Cocoa beans are a rich natural source of flavonoids. Unfortunately when cocoa is made into chocolate most of the flavonoids are destroyed. The aim of this study is to find out the effect of cocoa flavonoids on blood pressure after 12 weeks of daily consumption of a specially prepared chocolate drink that is rich in flavonoids.
- Conditions
- Hypertension
- Being tested
- Flavonoid rich or flavonoid depleted chocolate drink
- Keywords
- randomised double blind trial, blood pressure, cocoa flavonoids
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavonoid rich or flavonoid depleted chocolate drinkBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean 24 hour ambulatory blood pressure
Secondary outcomes (5)
Difference in cholesterol
Difference in glucose
Difference in insulin
Difference in echocardiogram
Difference in pulse wave velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startSep 2005
- Study completionJan 2006
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 Imperial College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- MasterFoods
- Investigators
- Neil R Poulter, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125866
- Sponsor's protocol ID
- NPSW01
- Status last verified
- Apr 2007
- First submitted
- 29 Jul 2005
- Last updated
- 28 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure
- ClinicalTrials.gov ID
- NCT00125866
- Acronym / sponsor ID
- NPSW01
- Conditions
- Hypertension
- Keywords
- randomised double blind trial, blood pressure, cocoa flavonoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- MasterFoods
- Study start
- Sep 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 2 Aug 2005 (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 this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.
Detailed description
Flavonoids are natural substances found in fruits and vegetables, tea and red wine. The investigators know that people who eat a diet rich in these foods are less likely to have heart disease. This, in part, may be due to the blood pressure lowering effect of flavonoids. Cocoa beans are a rich natural source of flavonoids. Unfortunately when cocoa is made into chocolate most of the flavonoids are destroyed. The aim of this study is to find out the effect of cocoa flavonoids on blood pressure after 12 weeks of daily consumption of a specially prepared chocolate drink that is rich in flavonoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females of any age.
- Diagnosis of hypertension and on antihypertensive treatment.
- Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (<150/90mmHg).
Key exclusion criteria (2 listed)
- Participation in another clinical trial.
- Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.
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 |
|---|---|---|
| Flavonoid rich or flavonoid depleted chocolate drink | Behavioural | – |
Primary outcome
Difference in mean 24 hour ambulatory blood pressure
5 secondary outcomes
Difference in cholesterol
Difference in glucose
Difference in insulin
Difference in echocardiogram
Difference in pulse wave velocity
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 28 May 2015.
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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.
Neil R Poulter principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoid rich or flavonoid depleted chocolate drink in people with Hypertension, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 2 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 28 May 2015. 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 Kingdom. 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.
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?
Difference in mean 24 hour ambulatory blood pressure. 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 28 May 2015.