The Effect of Creatine on Muscle Loss

Muscle Loss Clinical Trial

— CML  

Official title:

The Effect of Creatine Supplementation on Muscle Loss During Immobilisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894737
• Other study ID #: METC 13-3-023
• Status: Completed
• Phase: N/A
• First received: July 1, 2013
• Last updated: August 28, 2015
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people.

Description:

Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and strength will be determined and muscle biopsies will be collected before and immediately after immobilisation. A week after the cast is removed we will assess any differences in recovery between intervention groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male

• Aged from 18-35 years

• 18.5 < BMI < 30 kg/m2

Exclusion Criteria:

• (Family) history of thrombosis

• Smoking

• Recent surgery

• Performing regular resistance training more than once per week in the past year

• Any back/leg/knee/shoulder complaints which may interfere with the use of crutches

• Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin

• All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)

• Use of anti-coagulants

• Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)

Study Design

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

Related Conditions & MeSH terms

• Muscle Loss

Intervention

Other:
• Placebo supplementation
Seven days of one-legged knee immobilisation with placebo supplementation
• Creatine supplementation
Seven days of one-legged knee immobilisation with creatine supplementation.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in quadriceps muscle cross-sectional area (CSA)	immediately before and after 1 week of immobilisation, and after 1 week recovery, quadriceps CSA will be assessed	Before and after 1 week of immobilisation, and after 1 week of recovery	No
Secondary	change in muscle fiber type specific CSA	immediately before and after 1 week of immobilization, and after 1 week of natural recovery	Before and after 1 week of immobilisation, and after 1 week of recovery	No
Secondary	change in muscle strength	immediately before and after 1 week of immobilization, and after 1 week of natural recovery, one-repetition maximum (1RM) muscle strength will be assessed	before and after 1 week of immobilisation, and after 1 week of recovery	No