Muscle Protein SynthesisCODIAKNCT06435637
Effects of Ingesting Multiple Boluses of Collagen on Muscle & Skin Connective Protein Synthesis in Vivo in Humans
A study testing Collagen protein and Resistance exercise in people with Muscle Protein Synthesis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis
- What is being tested?
- Collagen protein and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 30 Jun 2025
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35 years
- Male
- Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
- 18.5 ≤ BMI ≤ 30 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
Who cannot join
- Female
- Smoking
- Musculoskeletal disorders
- Metabolic disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- Chronic use of gastric acid suppressing medication or anti-coagulants
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- Unstable weight over the last three months
- Diagnosed GI tract disorders or diseases
- Blood donation in the past 2 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6200 MD
Thorben Aussieker, MSc, t.aussieker@maastrichtuniversity.nl
Luc JC van Loon, PhD
About this study
Official title: Collagen Digestion and Amino Acid Absorption Kinetics and the Effect on Muscle & Skin
Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.
Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.
Read more
Study design: Double-blind, parallel-group, placebo-controlled intervention study.
Study population: 20 healthy young males, aged 18-35 years.
Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.
Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Collagen protein, Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen proteinDietary supplement
Ingestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise
Resistance exerciseBehavioural
A single resistance exercise session of the leg press and leg extension exercise
| Study group | Role | What they receive |
|---|---|---|
| Collagen protein | Experimental | 100 g of collagen peptides (in boluses) with vitamin C Receives: Dietary Supplement: Collagen protein; Behavioral: Resistance exercise |
| Placebo | Placebo comparator | Non-caloric placebo (flavoured water) drinks, with vitamin C. Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle connective protein synthesis rates rested leg
The primary analysis will be an independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.
Measured: one value calculated over 8 hours
Secondary outcomes (6)
Muscle connective protein synthesis rates exercised leg
Independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.
Measured: one value calculated over 8 hours
Myofibrillar protein synthesis rates rested leg
Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.
Measured: one value calculated over 8 hours
Myofibrillar protein synthesis rates exercised leg
Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.
Measured: one value calculated over 8 hours
Skin protein synthesis rates
Independent t-test, comparing postprandial skin protein synthesis rates over the 0-8 h period (i.e., one integrated value).
Measured: one value calculated over 8 hours
Plasma insulin concentrations
Plasma insulin concentrations
Measured: measured over the 8 hour post-prandial period
Plasma amino acids concentrations
Plasma amino acids concentrations
Measured: measured over the 8 hour post-prandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, parallel-group, placebo-controlled intervention study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435637
- Sponsor's protocol ID
- METC 22-018
- Acronym
- CODIAK
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Digestion and Amino Acid Absorption Kinetics and the Effect on Muscle & Skin
- ClinicalTrials.gov ID
- NCT06435637
- Acronym / sponsor ID
- CODIAK / METC 22-018
- Conditions
- Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 May 2024 (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.
Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.
Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.
Study design: Double-blind, parallel-group, placebo-controlled intervention study.
Study population: 20 healthy young males, aged 18-35 years.
Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.
Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, parallel-group, placebo-controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| Collagen protein | Experimental | Dietary Supplement: Collagen protein, Behavioral: Resistance exercise100 g of collagen peptides (in boluses) with vitamin C |
| Placebo | Placebo comparator | Behavioral: Resistance exerciseNon-caloric placebo (flavoured water) drinks, with vitamin C. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18-35 years
- Male
- Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
- 18.5 ≤ BMI ≤ 30 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
Key exclusion criteria (9 listed)
- Female
- Smoking
- Musculoskeletal disorders
- Metabolic disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
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 |
|---|---|---|
| Collagen proteinIngestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise | Dietary supplement | Collagen protein |
| Resistance exerciseA single resistance exercise session of the leg press and leg extension exercise | Behavioural | Collagen protein, Placebo |
Primary outcome
Muscle connective protein synthesis rates rested leg
Time frame: one value calculated over 8 hours
The primary analysis will be an independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.
6 secondary outcomes
Muscle connective protein synthesis rates exercised leg
Time frame: one value calculated over 8 hours
Myofibrillar protein synthesis rates rested leg
Time frame: one value calculated over 8 hours
Myofibrillar protein synthesis rates exercised leg
Time frame: one value calculated over 8 hours
Skin protein synthesis rates
Time frame: one value calculated over 8 hours
Plasma insulin concentrations
Time frame: measured over the 8 hour post-prandial period
Plasma amino acids concentrations
Time frame: measured over the 8 hour post-prandial period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- 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.
Luc JC van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen protein and Resistance exercise in people with Muscle Protein Synthesis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 May 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc JC van Loon, PhD (+31-43-3881397, l.vanloon@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle connective protein synthesis rates rested leg (time frame: one value calculated over 8 hours). 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 30 May 2024.