Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Bioavailability
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pure Epicatechin; Dietary Supplement: High flavan-3-ol cocoa

• Registration Number: NCT02221791
• Lead Sponsor: Wageningen University

Brief 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 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:

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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will consume 70g white chocolate + placebo capsules
Pure Epicatechin	Pure Epicatechin	Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
High flavan-3-ol cocoa	High flavan-3-ol cocoa	Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule

Primary Outcome Measures

Name	Time	Method
Change in Endothelium-dependent flow-mediated dilation as a result of high flavan-3-ol cocoa or pure epicatechin consumption.	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 Outcome Measures

Name	Time	Method
Changes in arterial augmentation index as measured by Pulse Wave Analysis	Baseline and 2 hours after consumption	Measured in triplicate using a SphygmoCor device at baseline and 2 hours after consumption
Bioavailability of plasma epicatechin metabolites	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
Bioavailability of urine epicatechin metabolites	24 hour urine samples	Urinary epicatechin metabolites will be measured in 24-hour urine samples
Change in nitric oxide as a result of high flavan-3-ol cocoa or pure epicatechin consumption	Baseline and 1 hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption	Plasma analysis of nitric oxide

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Netherlands