Muscle DamageNCT01110122
Effect of Whey Protein on Soccer Performance
A study testing Whey protein in people with Muscle Damage, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Rationale: During exercise protein breakdown in muscles is larger than protein synthesis. This negative muscle protein balance leads to increased muscle damage and thereby to a reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce muscle damage, many athletes use proteins. Read more about this study
- Who is it for?
- Ages 15 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Whey protein
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Jul 2010
- 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 15 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- performing soccer >1 year
- part of A \& B selection of AJAX
Who cannot join
- presence of lactose intolerance
- presence of illness
- presence of injury
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Ajax
Amsterdam
Niels Wijne, MD, .n.wijne@ajax.nl
Niels Wijne, MD
About this study
Official title: The Effect of Post-exercise Supplementation With Whey Protein Versus Carbohydrate on Soccer Performance.
Rationale: During exercise protein breakdown in muscles is larger than protein synthesis. This negative muscle protein balance leads to increased muscle damage and thereby to a reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce muscle damage, many athletes use proteins. In professional soccer players, considerable stress is placed on the musculoskeletal system. Recovery time is often too short for these players to restore homeostasis, which results in catabolic processes. This increases playing errors and will lead to lapses in concentration. Therefore, it is of great importance for a professional soccer team to be in optimal condition and a fast recovery after exercise is desirable to accomplish maximum performance. Supplementation with whey proteins is thought to support this.
Objective: To assess whether post-exercise supplementation with whey protein will lead to a better muscle recovery than supplementation with carbohydrates in Dutch soccer players between the age of 15 and 18 years old.
Read more
Study design: A double blind randomised controlled cross-over trial.
Study population: Healthy soccer players of the A and B selection of AJAX between the age of 15 and 18 years old.
Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout period. Treatment order will be randomly assigned.
Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test level 2 score and the vertical jump test. The scores will evaluate the soccer players' ability to repeatedly perform intense exercise and his potential to recover from this exercise.
- Conditions
- Muscle Damage
- Being tested
- Whey protein
- Keywords
- Muscle recovery, Intermittent exercise, Whey protein, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
20g, oral, dissolved in yoghurt-drink, after every training and match for 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle recovery
Recovery will be measured with the test scores on the Yo-Yo Intermittent Recovery Test level 2 and the Countermovement Jumping Test.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Investigators
- Ingeborg A Brouwer, PhD, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110122
- Sponsor's protocol ID
- AJA-PROT-IAB-001
- Status last verified
- Mar 2010
- First submitted
- 22 Apr 2010
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-exercise Supplementation With Whey Protein Versus Carbohydrate on Soccer Performance.
- ClinicalTrials.gov ID
- NCT01110122
- Acronym / sponsor ID
- AJA-PROT-IAB-001
- Conditions
- Muscle Damage
- Keywords
- Muscle recovery, Intermittent exercise, Whey protein, Soccer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 26 Apr 2010 (estimated)
- 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: During exercise protein breakdown in muscles is larger than protein synthesis. This negative muscle protein balance leads to increased muscle damage and thereby to a reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce muscle damage, many athletes use proteins. In professional soccer players, considerable stress is placed on the musculoskeletal system. Recovery time is often too short for these players to restore homeostasis, which results in catabolic processes. This increases playing errors and will lead to lapses in concentration. Therefore, it is of great importance for a professional soccer team to be in optimal condition and a fast recovery after exercise is desirable to accomplish maximum performance. Supplementation with whey proteins is thought to support this.
Objective: To assess whether post-exercise supplementation with whey protein will lead to a better muscle recovery than supplementation with carbohydrates in Dutch soccer players between the age of 15 and 18 years old.
Study design: A double blind randomised controlled cross-over trial.
Study population: Healthy soccer players of the A and B selection of AJAX between the age of 15 and 18 years old.
Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout period. Treatment order will be randomly assigned.
Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test level 2 score and the vertical jump test. The scores will evaluate the soccer players' ability to repeatedly perform intense exercise and his potential to recover from this exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- performing soccer >1 year
- part of A \& B selection of AJAX
Key exclusion criteria (3 listed)
- presence of lactose intolerance
- presence of illness
- presence of injury
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 protein20g, oral, dissolved in yoghurt-drink, after every training and match for 2 weeks | Dietary supplement | – |
Primary outcome
Muscle recovery
Time frame: 2 weeks
Recovery will be measured with the test scores on the Yo-Yo Intermittent Recovery Test level 2 and the Countermovement Jumping Test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
Related trials for Muscle Damage
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
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.
Ingeborg A Brouwer, PhD principal investigator
VU University of Amsterdam
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 in people with Muscle Damage, run by VU University of Amsterdam 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 2 inclusion and 3 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 26 Apr 2010. 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. 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 Ingeborg A Brouwer, PhD (+31-20-5987702, ingeborg.brouwer@falw.vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle recovery (time frame: 2 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 26 Apr 2010.