Clinical trial NCT02222415: Exercise Training in Healthy Young Men
Official title: The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gaining Skeletal Muscle Mass and Strength
Keywords: Muscle mass
Strength
Cross-sectional area
Protein
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Skeletal muscle fiber size
timeFrame: 12 weeks
Secondary outcomes:
measure: Quadriceps cross-sectional area
timeFrame: 12 weeks
measure: Whole body en regional body composition
timeFrame: 12 weeks
measure: 1RM strength
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: 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.
citation: Res 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.
citation: Snijders 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.