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NCT Number: NCT02221791

Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, 6703 HD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pure Epicatechin

Dietary Supplement

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

High flavan-3-ol cocoa

Dietary Supplement

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

Placebo

Dietary Supplement

Participants will consume 70g white chocolate + placebo capsules

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Plasma analysis of nitric oxide

  2. Changes in arterial augmentation index as measured by Pulse Wave Analysis

    Time frame: Baseline and 2 hours after consumption

    Measured in triplicate using a SphygmoCor device at baseline and 2 hours after consumption

  3. Bioavailability of plasma epicatechin metabolites

    Time frame: Baseline and 1hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption

    Plasma analysis of epicatechin metabolites will be measured up to 8 hours after consumption of high flavan-3-ol cocoa or pure epicatechin

  4. Bioavailability of urine epicatechin metabolites

    Time frame: 24 hour urine samples

    Urinary epicatechin metabolites will be measured in 24-hour urine samples

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Acronym: FLAVO2

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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