Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

NCT ID: NCT02221791

Last Updated: 2014-10-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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:

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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Endothelial Dysfunction Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pure Epicatechin

Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate

Group Type ACTIVE_COMPARATOR

Pure Epicatechin

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

High flavan-3-ol cocoa

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule

Placebo

Participants will consume 70g white chocolate + placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

High flavan-3-ol cocoa

Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will consume 70g white chocolate + placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hollman, Dr

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://voedingsonderzoek.wur.nl/flavo2

Website for the study (in dutch)

Other Identifiers

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FLAVO2

Identifier Type: -

Identifier Source: org_study_id

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