Gaining Skeletal Muscle Mass and StrengthNCT02222415
Exercise Training in Healthy Young Men
A study testing Exercise + Protein drink in people with Gaining Skeletal Muscle Mass and Strength, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. 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
- Gaining Skeletal Muscle Mass and Strength
- What is being tested?
- Exercise + Protein drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Feb 2012
- 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
- Male
- Healthy
- Age between 18 and 30 years
- BMI between 18.5 and 30 kg/m2
- Recreationally active, performing sports on a non-competitive basis between 2 and 5 hours p/wk
- Participants willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements
Who cannot join
- HbA1C level above 6.5%
- Fasted blood glucose level above 7 mmol/L
- Serum creatinine level beneath 60 or above 120 µmol/L
- Participants with a recent history or current state of COPD
- Participants with a recent history or current state of rheumatoid arthritis
- Participants with a recent history or current state of musculoskeletal/orthopedic disorders
Show all 12Show fewer
- Participants with a recent history or current state of renal disorder
- Participants with a recent history or current state of cognitive impairment
- Participants with orthopedic metal implants in the spine and/or upper/lower extremities
- Participants with lactose intolerance and/or dairy protein allergy
- Participants who are enrolled in an interventional biomedical research project or have received an investigational new drug or product with the last 30 days prior to screening.
- Participants on medication, including anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men
Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. Whether timed protein intake could augment the increase in muscle fiber size and/or satellite cell content following long-term exercise intervention remains to be established.
We hypothesize that protein supplementation before sleep, on both training and non-training days, during a 12 week resistance training program further increases type II muscle fibre cross sectional area when compared to the placebo group.
- Being tested
- Exercise + Protein drink
- Keywords
- Muscle mass, Strength, Cross-sectional area, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + Protein drinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Training + placebo drink | Placebo comparator | Exercise + non-caloric placebo drink Receives: Dietary Supplement: Exercise + Protein drink |
| Exercise + Protein drink | Experimental | exercise + Drink containing Protein, Carbohydrates and Fat Receives: Dietary Supplement: Exercise + Protein drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle fiber size
Skeletal muscle fiber size will be assessed by muscle biopsy sampling before, during and after the 12 wks intervention period.
Muscle fiber size will be expressed in µm2
Measured: 12 weeks
Secondary outcomes (3)
Quadriceps cross-sectional area
Quadriceps cross-sectional area will be assessed by CT-scan before and after the 12 wks intervention period.
Quadriceps cross-sectional area will be expressed in cm2
Measured: 12 weeks
Whole body en regional body composition
Body composition (whole-body as well as regional) well be determined by DXA-scan performed before and after the 12 wks intervention period.
Results will be expressed in kilograms
Measured: 12 weeks
1RM strength
Maximum muscle strength will be assessed before, during and after 12 wks of exercise training by means of a 1 rep max test and will be expressed in kilograms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gaining Skeletal Muscle Mass and StrengthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222415
- Sponsor's protocol ID
- MEC 11-03-45
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
PubMed 23134885Res PT, Groen B, Pennings B, Beelen M, Wallis GA, Gijsen AP, Senden JM, VAN Loon LJ. Protein ingestion before sleep improves postexercise overnight recovery. Med Sci Sports Exerc. 2012 Aug;44(8):1560-9. doi: 10.1249/MSS.0b013e31824cc363.
PubMed 22330017Snijders T, Res PT, Smeets JS, van Vliet S, van Kranenburg J, Maase K, Kies AK, Verdijk LB, van Loon LJ. Protein Ingestion before Sleep Increases Muscle Mass and Strength Gains during Prolonged Resistance-Type Exercise Training in Healthy Young Men. J Nutr. 2015 Jun;145(6):1178-84. doi: 10.3945/jn.114.208371. Epub 2015 Apr 29.
PubMed 25926415
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men
- ClinicalTrials.gov ID
- NCT02222415
- Acronym / sponsor ID
- MEC 11-03-45
- Keywords
- Muscle mass, Strength, Cross-sectional area, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Aug 2014 (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.
Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. Whether timed protein intake could augment the increase in muscle fiber size and/or satellite cell content following long-term exercise intervention remains to be established.
We hypothesize that protein supplementation before sleep, on both training and non-training days, during a 12 week resistance training program further increases type II muscle fibre cross sectional area when compared to the placebo group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training + placebo drink | Placebo comparator | Dietary Supplement: Exercise + Protein drinkExercise + non-caloric placebo drink |
| Exercise + Protein drink | Experimental | Dietary Supplement: Exercise + Protein drinkexercise + Drink containing Protein, Carbohydrates and Fat |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Healthy
- Age between 18 and 30 years
- BMI between 18.5 and 30 kg/m2
- Recreationally active, performing sports on a non-competitive basis between 2 and 5 hours p/wk
Key exclusion criteria (12 listed)
- HbA1C level above 6.5%
- Fasted blood glucose level above 7 mmol/L
- Serum creatinine level beneath 60 or above 120 µmol/L
- Participants with a recent history or current state of COPD
- Participants with a recent history or current state of rheumatoid arthritis
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 |
|---|---|---|
| Exercise + Protein drink | Dietary supplement | Exercise + Protein drink, Training + placebo drink |
Primary outcome
Skeletal muscle fiber size
Time frame: 12 weeks
Skeletal muscle fiber size will be assessed by muscle biopsy sampling before, during and after the 12 wks intervention period. Muscle fiber size will be expressed in µm2
3 secondary outcomes
Quadriceps cross-sectional area
Time frame: 12 weeks
Whole body en regional body composition
Time frame: 12 weeks
1RM strength
Time frame: 12 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 22 Aug 2014.
- Background: PubMed 23134885Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
- Background: PubMed 22330017Res PT, Groen B, Pennings B, Beelen M, Wallis GA, Gijsen AP, Senden JM, VAN Loon LJ. Protein ingestion before sleep improves postexercise overnight recovery. Med Sci Sports Exerc. 2012 Aug;44(8):1560-9. doi: 10.1249/MSS.0b013e31824cc363.
- Derived from this study: PubMed 25926415Snijders T, Res PT, Smeets JS, van Vliet S, van Kranenburg J, Maase K, Kies AK, Verdijk LB, van Loon LJ. Protein Ingestion before Sleep Increases Muscle Mass and Strength Gains during Prolonged Resistance-Type Exercise Training in Healthy Young Men. J Nutr. 2015 Jun;145(6):1178-84. doi: 10.3945/jn.114.208371. Epub 2015 Apr 29.
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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 Exercise + Protein drink in people with Gaining Skeletal Muscle Mass and Strength, 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 6 inclusion and 12 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 22 Aug 2014. 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?
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?
Skeletal muscle fiber size (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222415, which also lists 3 linked publications.
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 22 Aug 2014.