Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance

June 16, 2020 updated by: PepsiCo Global R&D
Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50 mg vitamin C, along with a power training exercise program, increases rate of force development (RFD) and performance in athletes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Davis, California, United States, 95616
        • UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male athletes between 18-30 years of age
  2. Currently participating in sport
  3. <3 musculoskeletal injuries in the past year
  4. No health or dietary restriction that would be affected by the supplementation protocol

Exclusion Criteria:

  1. History of more than 3 musculoskeletal injuries within the past 12 months
  2. Health, dietary restriction or diet that would be affected by the supplementation protocol
  3. Willing to eat similar dietary pattern the day before baseline testing and each exercise testing/intervention day

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hydrolyzed collagen and Vitamin C powder mix
20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water
Dietary supplement: Collagen and Vitamin C powder mix nutritional intervention
20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise
Other: Maximum power training exercise
Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
Placebo Comparator: Maltodextrin powder
20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water
Other: Maximum power training exercise
Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
Other: Maltodextrin placebo powder
20 g maltodextrin placebo daily, 60 min prior to exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal rate of force development (RFD) of isometric squat (MIS)
Time Frame: % change from baseline to week 1, week 2 and week 3
Force (N) over time (msec) for the maximum slope of the first 20% of the movement
% change from baseline to week 1, week 2 and week 3
Counter-movement jump (CMJ) rate of force development (RFD)
Time Frame: % change from baseline to week 1, week 2 and week 3
CMJ jump performance N/s/kg
% change from baseline to week 1, week 2 and week 3
Squat jump height rate of force development (RFD)
Time Frame: % change from baseline to week 1, week 2 and week 3
Squat jump height performance RFD/kg
% change from baseline to week 1, week 2 and week 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum peak force of maximal isometric squat (MIS)
Time Frame: % change from baseline to week 1, week 2 and week 3
Peak force (N)
% change from baseline to week 1, week 2 and week 3
Counter-movement jump (CMJ) net eccentric impulse
Time Frame: % change from baseline to week 1, week 2 and week 3
Jump performance max N/s/kg (Note: Eccentric is the drop down part of the CMJ)
% change from baseline to week 1, week 2 and week 3
Counter-movement jump (CMJ) net concentric impulse
Time Frame: % change from baseline to week 1, week 2 and week 3
Jump performance max N/s/kg (Note: Concentric is the movement upwards of the CMJ)
% change from baseline to week 1, week 2 and week 3
Leg stiffness assessment
Time Frame: % change from baseline to week 1, week 2 and week 3
Tendon stiffness mean per kg (N/m/kg)
% change from baseline to week 1, week 2 and week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PepsiCo Global R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keith Baar, PhD, University of California, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEP-1704

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.

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