- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222415
Exercise Training in Healthy Young Men
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Training + placebo drink
Exercise + non-caloric placebo drink
|
|
|
Experimental: Exercise + Protein drink
exercise + Drink containing Protein, Carbohydrates and Fat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps cross-sectional area
Time Frame: 12 weeks
|
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 |
12 weeks
|
|
Whole body en regional body composition
Time Frame: 12 weeks
|
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 |
12 weeks
|
|
1RM strength
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MEC 11-03-45
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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