- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214133
Effects of Epicatechin-rich Cocoa on Collagen Synthesis (coca-dose)
August 2, 2021 updated by: University of California, Davis
Determining an Optimal Dose of Epicatechin-Rich Chocolate and Its Effect on Performance
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Davis, California, United States, 95616
- Neurobiology, Physiology & Behaviour
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 23 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epicatechin Dose Response
This arm will investigate varying doses of epicatechin on procollagen type I N-terminal propeptide (PINP) at varying doses CON, 1, 2, 3 mg/kg body mass.
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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.
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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.
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An optimized dose of epicatechin-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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epicatechin-rich cocoa dose response
Time Frame: ~26 days
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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.
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~26 days
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Effect of the optimized dose of epicatechin-rich cocoa on performance
Time Frame: ~22 days
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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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~22 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keith Baar, PhD, UC Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2017
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
July 7, 2017
First Submitted That Met QC Criteria
July 7, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1020494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The individual participant data will not be made available to other researchers.
Any data shared will be published in a blinded manner.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Collagen Synthesis
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University of California, DavisCompleted
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