Endothelial DysfunctionFLAVO2NCT02221791
Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
A study testing Pure Epicatechin and High flavan-3-ol cocoa in people with Endothelial Dysfunction and Bioavailability, run by Wageningen University at 1 site in Netherlands.
Trial summary
Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers of vascular function and insulin resistance although the results were less pronounced than the majority of chocolate… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Bioavailability
- What is being tested?
- Pure Epicatechin and High flavan-3-ol cocoa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Oct 2014
- 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 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 40 and 80 years,
- BMI between > 20 and ≤ 30
- No reported current or previous metabolic diseases,
- No history of cardiovascular diseases,
- No history of renal, liver or thyroid diseases,
- No history of gastrointestinal diseases,
- No diagnosed diabetes mellitus,
- Fasting laboratory parameters within normal range as judged by the study physician: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, GGT), serum glucose and HDL, LDL and total cholesterol.
Who cannot join
- Body mass index >30 or ≤20 kg/m2
- Usage of CVD medication (e.g. anti-hypertensive and/or lipid-modifying medication, non-steroidal anti-inflammatory drugs, acetylsalicylic acid), antibiotics, corticosteroids or opioids and not able or willing to stop taking them from at least 4 weeks prior to the study
- Taking nutritional supplements and unwilling to discontinue
- Reported dietary habits: medically prescribed diet, slimming diet
- Reported average alcohol consumption greater than or equal to 3 glasses/d
- Reported intense sporting activities > 10 h/w
Show all 15Show fewer
- Weight loss or weight gain of 5 kg or more during the last 2 months
- Smokers
- Vegetarians
- Problems with consuming the supplements or following the study guidelines
- Recent blood donation (i.e. 1 month) prior to the study and/or planned donation during and shortly after the study period
- Not agreeing to be informed about unexpected and medically relevant personal test-results, or not agreeing that their general practitioner will be informed about these results
- Participation in another biomedical trial less than 2 months before the start of the study or at the same time
- No signed informed consent form
- Unable to comply with the study procedure (e.g. holidays, urine collection, blood sampling)
Trial locations and contacts
1 site in 1 country.
About this study
Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers of vascular function and insulin resistance although the results were less pronounced than the majority of chocolate intervention studies.
The food matrix of chocolate or other compounds present in chocolate could play a role in the bioavailability of flavonoids, resulting in these heightened improvements in vascular function.
In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid chocolate on markers of vascular function.
Read the detailed description
Twenty male participants between the ages of 40 and 80 will visit the university on three days, separated by a 2-week washout. During each visit the participants will, in random order, be allocated to one of the three interventions:
- High flavan-3-ol chocolate (70g) plus placebo capsule;
- White chocolate (70g) plus 100mg of epicatechin in capsule form;
- White chocolate (70g) plus placebo capsule; Measurements of vascular function will be taken before, and 2 hours after consumption of the supplements. In order to determine flavonoid bioavailability, 24-hour urine samples will be collected and 7 blood samples will be taken over a period of 8 hours.
The primary study parameter is the percentage change in Flow-Mediated Dilation (FMD) as a result of a high-flavonoid cocoa or epicatechin challenge. Additional study parameters include plasma flavonoid and nitric oxide concentrations as well as pulse wave analysis parameters.
- Conditions
- Endothelial Dysfunction, Bioavailability
- Being tested
- Pure Epicatechin, High flavan-3-ol cocoa, Placebo
- Keywords
- Flavan-3-ol, Flavonoids, Epicatechin, Cocoa, Chocolate, Endothelial function, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure EpicatechinDietary supplement
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
High flavan-3-ol cocoaDietary supplement
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
PlaceboDietary supplement
Participants will consume 70g white chocolate + placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Pure Epicatechin | Active comparator | Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate Receives: Dietary Supplement: Pure Epicatechin |
| High flavan-3-ol cocoa | Active comparator | Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule Receives: Dietary Supplement: High flavan-3-ol cocoa |
| Placebo | Placebo comparator | Participants will consume 70g white chocolate + placebo capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelium-dependent flow-mediated dilation as a result of high flavan-3-ol cocoa or pure epicatechin consumption.
Change in arterial diameter as a result of 5 minute arterial occlusion (200mmHg). Arterial diameter will be measured by means of ultrasonography.
Measured: Baseline and 2 hours after consumption
Secondary outcomes (4)
Change in nitric oxide as a result of high flavan-3-ol cocoa or pure epicatechin consumption
Plasma analysis of nitric oxide
Measured: Baseline and 1 hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption
Changes in arterial augmentation index as measured by Pulse Wave Analysis
Measured in triplicate using a SphygmoCor device at baseline and 2 hours after consumption
Measured: Baseline and 2 hours after consumption
Bioavailability of plasma epicatechin metabolites
Plasma analysis of epicatechin metabolites will be measured up to 8 hours after consumption of high flavan-3-ol cocoa or pure epicatechin
Measured: Baseline and 1hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption
Bioavailability of urine epicatechin metabolites
Urinary epicatechin metabolites will be measured in 24-hour urine samples
Measured: 24 hour urine samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Peter Hollman, Dr, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221791
- Sponsor's protocol ID
- FLAVO2
- Acronym
- FLAVO2
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
- ClinicalTrials.gov ID
- NCT02221791
- Acronym / sponsor ID
- FLAVO2 / FLAVO2
- Conditions
- Endothelial Dysfunction, Bioavailability
- Keywords
- Flavan-3-ol, Flavonoids, Epicatechin, Cocoa, Chocolate, Endothelial function, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Aug 2014 (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.
Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers of vascular function and insulin resistance although the results were less pronounced than the majority of chocolate intervention studies.
The food matrix of chocolate or other compounds present in chocolate could play a role in the bioavailability of flavonoids, resulting in these heightened improvements in vascular function.
In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid chocolate on markers of vascular function.
Detailed description
Twenty male participants between the ages of 40 and 80 will visit the university on three days, separated by a 2-week washout. During each visit the participants will, in random order, be allocated to one of the three interventions:
- High flavan-3-ol chocolate (70g) plus placebo capsule;
- White chocolate (70g) plus 100mg of epicatechin in capsule form;
- White chocolate (70g) plus placebo capsule; Measurements of vascular function will be taken before, and 2 hours after consumption of the supplements. In order to determine flavonoid bioavailability, 24-hour urine samples will be collected and 7 blood samples will be taken over a period of 8 hours.
The primary study parameter is the percentage change in Flow-Mediated Dilation (FMD) as a result of a high-flavonoid cocoa or epicatechin challenge. Additional study parameters include plasma flavonoid and nitric oxide concentrations as well as pulse wave analysis parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pure Epicatechin | Active comparator | Dietary Supplement: Pure EpicatechinParticipants will consume 100mg of epicatechin (capsule) + 70g white chocolate |
| High flavan-3-ol cocoa | Active comparator | Dietary Supplement: High flavan-3-ol cocoaParticipants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume 70g white chocolate + placebo capsules |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 40 and 80 years,
- BMI between > 20 and ≤ 30
- No reported current or previous metabolic diseases,
- No history of cardiovascular diseases,
- No history of renal, liver or thyroid diseases,
Key exclusion criteria (15 listed)
- Body mass index >30 or ≤20 kg/m2
- Usage of CVD medication (e.g. anti-hypertensive and/or lipid-modifying medication, non-steroidal anti-inflammatory drugs, acetylsalicylic acid), antibiotics, corticosteroids or opioids and not able or willing to stop taking them from at least 4 weeks prior to the study
- Taking nutritional supplements and unwilling to discontinue
- Reported dietary habits: medically prescribed diet, slimming diet
- Reported average alcohol consumption greater than or equal to 3 glasses/d
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 |
|---|---|---|
| Pure EpicatechinParticipants will consume 100mg of epicatechin (capsule) + 70g white chocolate | Dietary supplement | Pure Epicatechin |
| High flavan-3-ol cocoaParticipants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule | Dietary supplement | High flavan-3-ol cocoa |
| PlaceboParticipants will consume 70g white chocolate + placebo capsules | Dietary supplement | Placebo |
Primary outcome
Change in Endothelium-dependent flow-mediated dilation as a result of high flavan-3-ol cocoa or pure epicatechin consumption.
Time frame: Baseline and 2 hours after consumption
Change in arterial diameter as a result of 5 minute arterial occlusion (200mmHg). Arterial diameter will be measured by means of ultrasonography.
4 secondary outcomes
Change in nitric oxide as a result of high flavan-3-ol cocoa or pure epicatechin consumption
Time frame: Baseline and 1 hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption
Changes in arterial augmentation index as measured by Pulse Wave Analysis
Time frame: Baseline and 2 hours after consumption
Bioavailability of plasma epicatechin metabolites
Time frame: Baseline and 1hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption
Bioavailability of urine epicatechin metabolites
Time frame: 24 hour urine samples
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 15 Oct 2014.
- Website for the study (in dutch)Link provided by the sponsor.
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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.
Peter Hollman, Dr principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure Epicatechin and High flavan-3-ol cocoa in people with Endothelial Dysfunction and Bioavailability, run by Wageningen University at 1 site in Netherlands.
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 8 inclusion and 15 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 15 Oct 2014. 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 Netherlands. 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?
Change in Endothelium-dependent flow-mediated dilation as a result of high flavan-3-ol cocoa or pure epicatechin consumption. (time frame: Baseline and 2 hours after consumption). 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 15 Oct 2014.