ExerciseNCT05425407
Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and Function
A study testing whey protein and whey protein + collagen peptide in people with Exercise and Healthy Male Subjects, run by KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Healthy Male Subjects
- What is being tested?
- whey protein and whey protein + collagen peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Apr 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sports participation, including general fitness training, between 2 and 5 hours max per week
- Body mass index between 18.5 and 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Exercise, Healthy Male Subjects
- Being tested
- whey protein, whey protein + collagen peptide
- Keywords
- Whey protein, Collagen peptide, Muscle and tendon overload training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinDietary supplement
Daily 45g of whey protein supplementation during a three week eccentric training period
whey protein + collagen peptideDietary supplement
Daily 15g of whey protein and 20g collagen peptide supplementation during a three week eccentric training period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Only whey protein will be provided Receives: Dietary Supplement: whey protein |
| Collagen | Experimental | A mix of whey protein and collagen peptides will be provided Receives: Dietary Supplement: whey protein + collagen peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in countermovement jump performance
Change in jump height when performing a countermovement jump, measured via a force platform
Measured: 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
Change in maximal isometric knee-extension force (angle = 45°) of the right leg
Measured: 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
Change in anteroposterior thickness of the right patellar tendon
Measured: 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
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).
Measured: Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)
Secondary outcomes (5)
Change in pain perception at the muscular level (VAS scale)
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)
Measured: 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)
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)
Measured: 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
Change in blood concentration of creatine kinase (marker of muscle damage)
Measured: Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Change in the blood concentration of Interleukin 6 (IL-6)
Change in blood concentration of Interleukin 6 (IL-6; marker of inflammation)
Measured: 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)
Change in blood concentration of N-terminal propeptide of type I procollagen (P1NP; marker of collagen synthesis)
Measured: Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start12 Apr 2021
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Rousselot BVBA
- Responsible party
- Principal investigator, Peter Hespel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425407
- Sponsor's protocol ID
- S64402
- Status last verified
- Jun 2022
- First submitted
- 3 Aug 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05425407
- Acronym / sponsor ID
- S64402
- Conditions
- Exercise, Healthy Male Subjects
- Keywords
- Whey protein, Collagen peptide, Muscle and tendon overload training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Rousselot BVBA
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: whey proteinOnly whey protein will be provided |
| Collagen | Experimental | Dietary Supplement: whey protein + collagen peptideA mix of whey protein and collagen peptides will be provided |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sports participation, including general fitness training, between 2 and 5 hours max per week
- Body mass index between 18.5 and 25
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey proteinDaily 45g of whey protein supplementation during a three week eccentric training period | Dietary supplement | Placebo |
| whey protein + collagen peptideDaily 15g of whey protein and 20g collagen peptide supplementation during a three week eccentric training period | Dietary supplement | Collagen |
Primary outcome
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
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
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
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).
5 secondary outcomes
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 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 the blood concentration of creatine kinase
Time frame: 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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein and whey protein + collagen peptide in people with Exercise and Healthy Male Subjects, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.