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OpenTrials
Completed

NCT Number: NCT02222415

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.

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Key information

Conditions

Gaining Skeletal Muscle Mass and Strength

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise + Protein drink

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.