Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
NCT ID: NCT02221791
Last Updated: 2014-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-06-30
2014-10-31
Brief Summary
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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.
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Detailed Description
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1. High flavan-3-ol chocolate (70g) plus placebo capsule;
2. White chocolate (70g) plus 100mg of epicatechin in capsule form;
3. 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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Pure Epicatechin
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
Pure Epicatechin
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
High flavan-3-ol cocoa
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
High flavan-3-ol cocoa
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
Placebo
Participants will consume 70g white chocolate + placebo capsules
Placebo
Participants will consume 70g white chocolate + placebo capsules
Interventions
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Pure Epicatechin
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
High flavan-3-ol cocoa
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
Placebo
Participants will consume 70g white chocolate + placebo capsules
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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)
40 Years
80 Years
MALE
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Peter Hollman, Dr
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Locations
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Wageningen University
Wageningen, , Netherlands
Countries
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Related Links
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Website for the study (in dutch)
Other Identifiers
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FLAVO2
Identifier Type: -
Identifier Source: org_study_id
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