Effects of Epicatechin-rich Cocoa on Collagen Synthesis

NCT03214133 | Completed DMC

• 1 other identifier: 1020494
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Collagen Synthesis

Outcome Measures

Primary Outcomes (2)

• Epicatechin-rich cocoa dose response

  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.

  ~26 days

• Effect of the optimized dose of epicatechin-rich cocoa on performance

  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.

  ~22 days

Study Arms (2)

Epicatechin Dose Response

EXPERIMENTAL

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.

Other: Epicatechin-rich cocoa dose response

Epicatechin-rich cocoa on performance

PLACEBO COMPARATOR

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

Interventions

Epicatechin-rich cocoa dose response OTHER

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.

Epicatechin Dose Response

Epicatechin-rich cocoa vs placebo on performance OTHER

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.

Epicatechin-rich cocoa on performance

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Neurobiology, Physiology & Behaviour

Davis, California, 95616, United States

Location

Study Officials

• Keith Baar, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Alkalized (0.01 mg epicatechin/g) ) and non alkalized cocoa (4.1 mg epicatechin/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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: May 23, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)