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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02222415
Other study ID # MEC 11-03-45
Secondary ID
Status Completed
Phase N/A
First received August 20, 2014
Last updated August 21, 2014
Start date October 2011
Est. completion date February 2012

Study information

Verified date August 2014
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • Gaining Skeletal Muscle Mass and Strength

Intervention

Dietary Supplement:
Exercise + Protein drink


Locations

Country Name City State
Netherlands Maastricht University Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No