Clinical trial NCT03214133: Effects of Epicatechin-rich Cocoa on Collagen Synthesis
Official title: Determining an Optimal Dose of Epicatechin-Rich Chocolate and Its Effect on Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collagen Synthesis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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).

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.

Eligibility 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.

Primary outcomes:
measure: Epicatechin-rich cocoa dose response
timeFrame: ~26 days
measure: Effect of the optimized dose of epicatechin-rich cocoa on performance
timeFrame: ~22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Neurobiology, Physiology & Behaviour
state: California
Study officials:
affiliation: UC Davis
name: Keith Baar, PhD
role: PRINCIPAL_INVESTIGATOR
References: