Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

Endothelial Dysfunction Clinical Trial

— FLAVO2  

Official title:

Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221791
• Other study ID #: FLAVO2
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: October 14, 2014
• Start date: June 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 2 hours after consumption	No
Secondary	Change in nitric oxide as a result of high flavan-3-ol cocoa or pure epicatechin consumption	Plasma analysis of nitric oxide	Baseline and 1 hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption	No
Secondary	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	Baseline and 2 hours after consumption	No
Secondary	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	Baseline and 1hr, 2hr, 3hr, 4hr, 6hr and 8hr after consumption	No
Secondary	Bioavailability of urine epicatechin metabolites	Urinary epicatechin metabolites will be measured in 24-hour urine samples	24 hour urine samples	No

External Links

•   Website for the study (in dutch)