Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and Function

June 16, 2022 updated by: Peter Hespel, KU Leuven

A Randomized Double-blinded Placebo-controlled Study to Evaluate the Effect of Collagen Peptide (Collagen Peptan) Supplementation on Muscle and Tendon Damage, Repair, and Functional Capacity During Exercise Training Overload

The aim of the study is to investigate the acute and short-term effects of collagen peptides (Collagen Peptan) on muscle and connective tissue during an eccentric overload training period. Currently, all studies investigating the effects of post-exercise collagen supplementation did this in the absence of whey proteins, which are part of the standard recommendations for post-exercise recovery. The investigators will therefore investigate whether the combined intake of whey proteins and collagen peptides ensures a better recovery of exercise performance and whether it can prevent or reduce symptoms of muscle and tendon overload during a three-week eccentric overload training period (n = 22).

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.
22

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

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3001
        • Exercise Physiology Research Group

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Sports participation, including general fitness training, between 2 and 5 hours max per week
  • Body mass index between 18.5 and 25

Exclusion Criteria:

  • Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise - Intake of any medication or nutritional supplement that could impact muscle protein synthesis and/or exercise performance during the period of the study
  • Intake of any whey protein, casein of branched-chain amino acid (BCAA) supplements from 1 month prior to the start of the study
  • Blood donation within 3 months prior to the start of the study
  • Smoking
  • Current participation in another research trial
  • Any other argument to believe that the subject is unlikely to successfully complete the full study

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: Prevention
  • 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.
Placebo Comparator: Placebo
Only whey protein will be provided
Dietary supplement: whey protein
Daily 45g of whey protein supplementation during a three week eccentric training period
Experimental: Collagen
A mix of whey protein and collagen peptides will be provided
Dietary supplement: whey protein + collagen peptide
Daily 15g of whey protein and 20g collagen peptide supplementation during a three week eccentric training period

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
Change in countermovement jump performance
Time Frame: Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in jump height when performing a countermovement jump, measured via a force platform
Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in maximal isometric knee-extension force of the right leg
Time Frame: Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in maximal isometric knee-extension force (angle = 45°) of the right leg
Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in anteroposterior thickness of the right patellar tendon
Time Frame: Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in anteroposterior thickness of the right patellar tendon
Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in neovascularization of the right patellar tendon
Time Frame: Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Neovascularization of the right patellar tendon scored with the Modified Ohberg Score (range 0 - 4; the higher the score, the higher the degree of neovascularization).
Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain perception at the muscular level (VAS scale)
Time Frame: Training 1 (day 1 of training intervention) - Training 2 (day 3 of training intervention) - Training 8 (day 9 of training intervention) - Training 17 (day 19 of training intervention) - Posttest (day 22 of training intervention)
Change in pain perception at the muscular level of the right leg, measured via the Visual Analogue Scale (range 0 - 10; the higher the score, the higher the pain level)
Training 1 (day 1 of training intervention) - Training 2 (day 3 of training intervention) - Training 8 (day 9 of training intervention) - Training 17 (day 19 of training intervention) - Posttest (day 22 of training intervention)
Change in pain perception of the patellar tendon of the right leg (VISA-P)
Time Frame: Pretest - Training 1 (day 1 of training intervention) - Training 17 (day 21 of training intervention) - Posttest (day 22 of training intervention)
Change in pain perception of the patellar tendon of the right leg, measured via the VISA-P questionnaire (range: 0 - 100; the lower the score, the higher the symptoms of patellar tendon overload)
Pretest - Training 1 (day 1 of training intervention) - Training 17 (day 21 of training intervention) - Posttest (day 22 of training intervention)
Change in the blood concentration of creatine kinase
Time Frame: Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in blood concentration of creatine kinase (marker of muscle damage)
Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in the blood concentration of Interleukin 6 (IL-6)
Time Frame: Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in blood concentration of Interleukin 6 (IL-6; marker of inflammation)
Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in the blood concentration of N-terminal propeptide of type I procollagen (P1NP)
Time Frame: Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in blood concentration of N-terminal propeptide of type I procollagen (P1NP; marker of collagen synthesis)
Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)

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.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rousselot BVBA

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.
April 12, 2021

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.
May 30, 2021

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.
June 30, 2021

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).
August 3, 2021

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, 2022

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 21, 2022

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 21, 2022

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, 2022

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, 2022

More Information

Terms related to this study

Keywords

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.
  • S64402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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