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Trial record 17 of 84 for:    catechin

Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function (FLAVO2)

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ClinicalTrials.gov Identifier: NCT02221791
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Bioavailability Dietary Supplement: Pure Epicatechin Dietary Supplement: High flavan-3-ol cocoa Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arm Intervention/treatment
Active Comparator: Pure Epicatechin
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
Dietary Supplement: Pure Epicatechin
Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate

Active Comparator: High flavan-3-ol cocoa
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
Dietary Supplement: High flavan-3-ol cocoa
Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule

Placebo Comparator: Placebo
Participants will consume 70g white chocolate + placebo capsules
Dietary Supplement: Placebo
Participants will consume 70g white chocolate + placebo capsules




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221791


Locations
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Netherlands
Wageningen University
Wageningen, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
Top Institute Food and Nutrition
Investigators
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Principal Investigator: Peter Hollman, Dr Wageningen University

Additional Information:
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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02221791     History of Changes
Other Study ID Numbers: FLAVO2
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: August 2014

Keywords provided by Wageningen University:
Flavan-3-ol
Flavonoids
Epicatechin
Cocoa
Chocolate
Endothelial function
Bioavailability