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Effects of Epicatechin-rich Cocoa on Collagen Synthesis (coca-dose)

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ClinicalTrials.gov Identifier: NCT03214133
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This study will investigate the effects of dietary supplementation of epicatechin-rich cocoa in humans on collagen synthesis and power-based performance outcomes (rate of force development).

Condition or disease Intervention/treatment Phase
Collagen Synthesis Other: Epicatechin-rich cocoa dose response Other: Epicatechin-rich cocoa vs placebo on performance Not Applicable

Detailed Description:
The investigators have recently completed a study looking at the expression of the collagens following consumption of increasing doses of epicatechin in rats . This data clearly shows that increasing doses of epicatechin, either 0.5 mg.kg-1 delivered once, twice, or three times a day, or 2 mg.kg-1 once a day, results in increasing expression of the fibrillar collagens (I, III, and V). This preliminary data suggests that epicatechin-rich chocolate supplementation can increase collagen expression in humans and that this may improve force transfer. From this background, the hypothesis proposed is that supplementation with epicatechin-rich chocolate will increase rate of force development and performance in athletes. Therefore, this simple nutrition intervention has the potential to simultaneously improve performance, decrease injuries and accelerate return to competition through improved collagen synthesis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Arm 1 of the project will employ a randomized single-blinded crossover design with subjects completing all 4 of the epicatechin-rich chocolate trials (0, 1, 2 and 3 mg.kg-1). Arm 2 will use a randomized parallel double-blind design with neither the subjects nor the investigators knowing who is on which treatment (optimized epicatechin-rich chocolate dose or Dutch processed/epicatechin depleted placebo.
Masking: Double (Participant, Investigator)
Masking Description:

Alkalized (0.01 mg epicatechin/g) ) and non alkalized cocoa (4.1 mg epicaetchin/g) will be mixed in various ratios to achieve the desired 0, 1, 2, 3 mg/ kg body mass but maintaining equally weighed dose of cocoa for each intervention.

For Arm 2, the same quantity of either alkalized or non alkalized cocoa will be given to achieve the optimized dosed of epicatechin.

Primary Purpose: Other
Official Title: Determining an Optimal Dose of Epicatechin-Rich Chocolate and Its Effect on Performance
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : February 6, 2020
Estimated Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arm Intervention/treatment
Experimental: Epicatechin Dose Response
This arm will investigate varying doses of epicatchin on procollagen type I N-terminal propeptide (PINP) at varying doses CON, 1, 2, 3 mg/kg body mass.
Other: Epicatechin-rich cocoa dose response
Subjects consume randomized doses of 0, 1, 2, 3 mg epicatechin/kg from epicatechin-rich cocoa. The optimal dose of epicatechin-rich chocolate will be the dose which have the greatest increase PNIP levels.

Placebo Comparator: Epicatechin-rich cocoa on performance
Athletes will ingest the optimized dose of epicatechin-rich cocoa vs placebo alongside maximum power training to determine if this nutritional intervention results in a greater increase in RFD and performance than maximum power training alone.
Other: Epicatechin-rich cocoa vs placebo on performance
An optimized dose of epictechin-rich cocoa or placebo will be given for 3 weeks alongside a prescribed power-based training program. In a randomized parallel design the effect of the optimal dose of epicatechin-rich chocolate, compared to placebo, on maximal isometric squat force, RFD, and jump testing will be quantified.




Primary Outcome Measures :
  1. Epicatechin-rich cocoa dose response [ Time Frame: ~26 days ]
    investigating effects doses of 0, 1, 2, 3 mg epicatechin/kg/day procollagen type I N-terminal propeptide (PINP) in the blood after 5 days of supplementation with 2-day wash out between.

  2. Effect of the optimized dose of epicatechin-rich cocoa on performance [ Time Frame: ~22 days ]
    Performance measures (of rate of force development) will be quantified for 3 weeks alongside the ingestion of an optimized dose of epicatechin-rich cocoa vs placebo.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Collegiate level male athletes between the ages of 18¬-25 years of age, currently participating in sport, will be recruited to participate in the study.

Exclusion Criteria:

  • History of more than 3 musculoskeletal injuries within the past 12 months.
  • Health and dietary restriction (e.g. lactose intolerance) that would be affected by the supplementation protocol.
  • The initial phase will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen synthesis is the main outcome measure for the study this would confound the initial phase of the work. Provided this work proves successful then the investigators will aim to proceed with similar research in females.

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): NCT03214133


Contacts
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Contact: Dana M Lis, PhD 530-304-5873 dmlis@ucdavis.edu
Contact: Keith Baar, PhD 530-400-2188 kbaar@ucdavis.edu

Locations
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United States, California
Neurobiology, Physiology & Behaviour Recruiting
Davis, California, United States, 95616
Contact: Keith Baar, PhD    530-400-2188    kbaar@ucdavis.ecu   
Contact: Dana M Lis, PhD    530-304-5873    dmlis@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Keith Baar, PhD UC Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03214133     History of Changes
Other Study ID Numbers: 1020494
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will not be made available to other researchers. Any data shared will be published in a blinded manner.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No