The Effect of Creatine on Muscle Loss (CML)

August 28, 2015 updated by: Maastricht University Medical Center

The Effect of Creatine Supplementation on Muscle Loss During Immobilisation

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Maastricht, Limburg, Netherlands, 6200MD
        • Maastricht University Medical Centre+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: immobilisation and placebo
Seven days of one-legged knee immobilisation with placebo supplementation
Seven days of one-legged knee immobilisation with placebo supplementation
Experimental: immobilisation and creatine
Seven days of one-legged knee immobilisation with creatine supplementation
Seven days of one-legged knee immobilisation with creatine supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in quadriceps muscle cross-sectional area (CSA)
Time Frame: Before and after 1 week of immobilisation, and after 1 week of recovery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in muscle fiber type specific CSA
Time Frame: Before and after 1 week of immobilisation, and after 1 week of recovery
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
change in muscle strength
Time Frame: before and after 1 week of immobilisation, and after 1 week of recovery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • METC 13-3-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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