Cardiovascular DiseaseNCT01312584
The Effects of Alkalised Cocoa on Human Vascular Function
A study testing Processed High-flavanol in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
Trial summary
The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Processed High-flavanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Sep 2010
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- signed consent form
- age of 18-35 years inclusive
- BMI between 18.5-30
Who cannot join
- Blood pressure > 150/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any reproductive disorder
Show all 16Show fewer
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
- Drinking more than 21 units per week
- On any lipid-modifying medication
- On any blood pressure lowering medication
- On any medication affecting blood clotting
- Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
- Regular or vigorous exercise (3 times/week, 20 minutes each session)
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols
The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa
Read the detailed description
A randomised, triple blind, cross-over design human intervention studies will be conducted in 10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism and vascular reactivity of cocoa flavanols. Participants will be requested to consume a standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and micronutrient content. Vascular measurements will be performed by using Flow Mediated Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine samples will be taken to measure the concentration of flavonoids from the cocoa drinks and markers of blood vessel function. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.
- Conditions
- Cardiovascular Disease
- Being tested
- Processed High-flavanol
- Keywords
- Flavanol, Cocoa, Vascular function, Absorption, Metabolism, Alkalisation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed High-flavanolDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Non alkalised High Flavanol | Placebo comparator | Non-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols Receives: Dietary Supplement: Processed High-flavanol |
| Alkalised high Flavanol | Active comparator | Alkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols Receives: Dietary Supplement: Processed High-flavanol |
| Alkalised Low Flavanol | Active comparator | Alkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols Receives: Dietary Supplement: Processed High-flavanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa.
Flow Mediated Dilation
Measured: change in Flow Mediated Dilation response between baseline and 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Investigators
- Jeremy Spencer, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312584
- Sponsor's protocol ID
- UReading-2010-01
- Status last verified
- Nov 2010
- First submitted
- 9 Mar 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols
- ClinicalTrials.gov ID
- NCT01312584
- Acronym / sponsor ID
- UReading-2010-01
- Conditions
- Cardiovascular Disease
- Keywords
- Flavanol, Cocoa, Vascular function, Absorption, Metabolism, Alkalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 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.
The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa
Detailed description
A randomised, triple blind, cross-over design human intervention studies will be conducted in 10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism and vascular reactivity of cocoa flavanols. Participants will be requested to consume a standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and micronutrient content. Vascular measurements will be performed by using Flow Mediated Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine samples will be taken to measure the concentration of flavonoids from the cocoa drinks and markers of blood vessel function. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non alkalised High Flavanol | Placebo comparator | Dietary Supplement: Processed High-flavanolNon-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols |
| Alkalised high Flavanol | Active comparator | Dietary Supplement: Processed High-flavanolAlkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols |
| Alkalised Low Flavanol | Active comparator | Dietary Supplement: Processed High-flavanolAlkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- signed consent form
- age of 18-35 years inclusive
- BMI between 18.5-30
Key exclusion criteria (16 listed)
- Blood pressure > 150/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
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 |
|---|---|---|
| Processed High-flavanol | Dietary supplement | Alkalised Low Flavanol, Alkalised high Flavanol, Non alkalised High Flavanol |
Primary outcome
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa.
Time frame: change in Flow Mediated Dilation response between baseline and 2h
Flow Mediated Dilation
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 10 Mar 2011.
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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.
Jeremy Spencer, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed High-flavanol in people with Cardiovascular Disease, run by University of Reading 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 4 inclusion and 16 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 10 Mar 2011. 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. 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.
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?
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa. (time frame: change in Flow Mediated Dilation response between baseline and 2h). 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 10 Mar 2011.