- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425407
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Only whey protein will be provided
|
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
|
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
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
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
Collaborators
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)
April 12, 2021
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
August 3, 2021
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 16, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID 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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