Exercise Training in Healthy Young Men

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men

Conditions
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Gaining Skeletal Muscle Mass and Strength

Intervention / Treatment
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* Dietary Supplement: Exercise + Protein drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Training + placebo drink<br>Exercise + non-caloric placebo drink | Dietary Supplement: Exercise + Protein drink<br> <br> |
| Experimental: Exercise + Protein drink<br>exercise + Drink containing Protein, Carbohydrates and Fat | Dietary Supplement: Exercise + Protein drink<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle mass, Strength, Cross-sectional area, Protein