NCT01894737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

July 1, 2013

Last Update Submit

August 28, 2015

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • change in muscle fiber type specific CSA

    Before and after 1 week of immobilisation, and after 1 week of recovery

  • change in muscle strength

    before and after 1 week of immobilisation, and after 1 week of recovery

Study Arms (2)

immobilisation and placebo

PLACEBO COMPARATOR

Seven days of one-legged knee immobilisation with placebo supplementation

Other: Placebo supplementation

immobilisation and creatine

EXPERIMENTAL

Seven days of one-legged knee immobilisation with creatine supplementation

Other: Creatine supplementation

Interventions

Placebo supplementationOTHER

Seven days of one-legged knee immobilisation with placebo supplementation

immobilisation and placebo
Creatine supplementationOTHER

Seven days of one-legged knee immobilisation with creatine supplementation.

immobilisation and creatine

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged from 18-35 years
  • \< BMI \< 30 kg/m2

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

Location

Related Publications (2)

  • Backx EMP, Hangelbroek R, Snijders T, Verscheijden ML, Verdijk LB, de Groot LCPGM, van Loon LJC. Creatine Loading Does Not Preserve Muscle Mass or Strength During Leg Immobilization in Healthy, Young Males: A Randomized Controlled Trial. Sports Med. 2017 Aug;47(8):1661-1671. doi: 10.1007/s40279-016-0670-2.

    PMID: 28054322DERIVED

  • Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.

    PMID: 27124248DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Creatine

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Luc van Loon, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 10, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

NL(1)