Muscle Strength RecoveryNCT03063346
The Effect of a Protein Hydrolysate on Muscle Strength Recovery
A study testing Protein hydrolysate high dose and Protein hydrolysate low dose in people with Muscle Strength Recovery, run by BioActor.
Trial summary
Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength Recovery
- What is being tested?
- Protein hydrolysate high dose and Protein hydrolysate low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2016to 20 Feb 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (based on their medical history provided during a general health questionnaire)
- Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in >6 hours of intense physical activity per week).
- Age 18 - 35
- Experience in resistance training
Who cannot join
- Use of creatine supplements and/or anabolic steroids.
- Allergy to test product/protein
- Allergy to specific protein hydrolysate
- BMI lower than 18 or higher than 30.
- Lack of technique in correctly performing a barbell squat (judged by sports physiologist).
- Recent muscle injury in legs or back less than one month before the start of the study.
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- Cardiovascular complications
- Use of medication
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Abuse of products; alcohol (> 20 alcoholic units per week) and drugs
About this study
Official title: The Effect of a Protein Hydrolysate on Muscle Strength Recovery in Athletes
Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. This causes increased muscle tissue damage after intense exercise, which slows down recovery. Improving recovery may increase an athlete's ability to reach higher training volumes resulting in establishing a higher performance plateau.
It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate may have positive effects on strength recovery.
- Conditions
- Muscle Strength Recovery
- Being tested
- Protein hydrolysate high dose, Protein hydrolysate low dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein hydrolysate high doseDietary supplement
Protein hydrolysate low doseDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Protein hydrolysate high dose | Experimental | Not described Receives: Dietary Supplement: Protein hydrolysate high dose |
| Protein hydrolysate low dose | Experimental | Not described Receives: Dietary Supplement: Protein hydrolysate low dose |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength recovery
difference in peak force between the exhaustion challenge and the recovery challenge, measured with a linear encoder during a squat exercise
Measured: 4 weeks
Secondary outcomes (4)
Blood lactate buildup
in mmol/L, measured trough a finger prick after exhaustion and recovery challenge
Measured: 4 weeks
Body composition
fat percentage, based on 4-point skin fold measurement
Measured: 4 weeks
Exercise volume
amount of repetitions x time taken x power, measured with a linear encoder during squat exercise
Measured: 4 weeks
Peak force output
measured with a linear encoder during the squat exercise
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start6 Jun 2016
- Primary completion9 Feb 2017
- Study completion20 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Strength RecoveryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioActor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063346
- Sponsor's protocol ID
- MU-001
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Protein Hydrolysate on Muscle Strength Recovery in Athletes
- ClinicalTrials.gov ID
- NCT03063346
- Acronym / sponsor ID
- MU-001
- Conditions
- Muscle Strength Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BioActorIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 20 Feb 2017 (actual)
- First posted
- 24 Feb 2017 (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.
Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. This causes increased muscle tissue damage after intense exercise, which slows down recovery. Improving recovery may increase an athlete's ability to reach higher training volumes resulting in establishing a higher performance plateau.
It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate may have positive effects on strength recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein hydrolysate high dose | Experimental | Dietary Supplement: Protein hydrolysate high dose |
| Protein hydrolysate low dose | Experimental | Dietary Supplement: Protein hydrolysate low dose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy individuals (based on their medical history provided during a general health questionnaire)
- Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in >6 hours of intense physical activity per week).
- Age 18 - 35
- Experience in resistance training
Key exclusion criteria (10 listed)
- Use of creatine supplements and/or anabolic steroids.
- Allergy to test product/protein
- Allergy to specific protein hydrolysate
- BMI lower than 18 or higher than 30.
- Lack of technique in correctly performing a barbell squat (judged by sports physiologist).
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 |
|---|---|---|
| Protein hydrolysate high dose | Dietary supplement | Protein hydrolysate high dose |
| Protein hydrolysate low dose | Dietary supplement | Protein hydrolysate low dose |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Muscle strength recovery
Time frame: 4 weeks
difference in peak force between the exhaustion challenge and the recovery challenge, measured with a linear encoder during a squat exercise
4 secondary outcomes
Blood lactate buildup
Time frame: 4 weeks
Body composition
Time frame: 4 weeks
Exercise volume
Time frame: 4 weeks
Peak force output
Time frame: 4 weeks
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 3 Mar 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Protein hydrolysate high dose and Protein hydrolysate low dose in people with Muscle Strength Recovery, run by BioActor.
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 4 inclusion and 10 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscle strength recovery (time frame: 4 weeks). 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 3 Mar 2017.