Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

NCT02221791 | Completed

• 1 other identifier: FLAVO2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Bioavailability

Keywords

Flavan-3-ol; Flavonoids; Epicatechin; Cocoa; Chocolate; Endothelial function; Bioavailability

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• Changes in arterial augmentation index as measured by Pulse Wave Analysis

  Baseline and 2 hours after consumption

• Bioavailability of plasma epicatechin metabolites

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

• Bioavailability of urine epicatechin metabolites

  24 hour urine samples

Study Arms (3)

Pure Epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: Pure Epicatechin

High flavan-3-ol cocoa

ACTIVE COMPARATOR

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

Dietary Supplement: High flavan-3-ol cocoa

Placebo

PLACEBO COMPARATOR

Participants will consume 70g white chocolate + placebo capsules

Dietary Supplement: Placebo

Interventions

Pure Epicatechin DIETARY_SUPPLEMENT

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

Pure Epicatechin

High flavan-3-ol cocoa DIETARY_SUPPLEMENT

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

High flavan-3-ol cocoa

Placebo DIETARY_SUPPLEMENT

Participants will consume 70g white chocolate + placebo capsules

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wageningen University: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Wageningen University

Wageningen, 6703 HD, Netherlands

Location

Related Links

• Website for the study (in dutch)

Study Officials

• Peter Hollman, Dr

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-08

Locations

NL (1)