NCT00936039

Brief Summary

In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

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 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

3.3 years

First QC Date

July 6, 2009

Last Update Submit

July 1, 2013

Conditions

ImmobilizationPhysical Inactivity

Outcome Measures

Primary Outcomes (1)

  • muscle mass, muscle fiber size

    1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading

Secondary Outcomes (1)

  • muscle strength

    1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading

Study Arms (1)

unloading

EXPERIMENTAL

2 weeks of unloading

Behavioral: unloading

Interventions

unloadingBEHAVIORAL

2 weeks of unloading of a single leg

unloading

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • BMI \< 30 kg/m2

You may not qualify if:

  • Use of medication that may affect haemostasis
  • Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches
  • Subjects with metal implants in their lower limbs
  • Subjects with known cardiovascular and/or haemostasis disorders
  • Subjects with known severe hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6200MD, Netherlands

Location

Related Publications (1)

  • Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

    PMID: 32069356DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Luc JC van Loon, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 9, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

NL(1)