Exercise Training in Healthy Young Men

Not Applicable

Completed

• Conditions: Gaining Skeletal Muscle Mass and Strength
• Interventions: Dietary Supplement: Exercise + Protein drink

• Registration Number: NCT02222415
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training + placebo drink	Exercise + Protein drink	Exercise + non-caloric placebo drink
Exercise + Protein drink	Exercise + Protein drink	exercise + Drink containing Protein, Carbohydrates and Fat

Primary Outcome Measures

Name	Time	Method
Skeletal muscle fiber size	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

Secondary Outcome Measures

Name	Time	Method
Quadriceps cross-sectional area	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
Whole body en regional body composition	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
1RM strength	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.

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands