Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001391369
Ethics application status
Approved
Date submitted
26/09/2017
Date registered
29/09/2017
Date last updated
29/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Profiling skeletal muscle loss during leg immobilisation and a reduced energy diet
Scientific title
Effect of reduced energy availability on skeletal muscle loss during leg immobilisation in healthy male adults
Secondary ID [1] 292527 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal muscle atrophy 304175 0
Condition category
Condition code
Musculoskeletal 304234 304234 0 0
Other muscular and skeletal disorders
Injuries and Accidents 304235 304235 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
14 days of limb (leg) immobilisation will be undertaken using a Donjoy X-ACT ROM Universal leg brace worn 24 h per day. This intervention will be combined with a 30% energy restriction over the 14 day immobilisation period. All foods will be provided to participants and supplied by a commercial provider (Lite 'n' easy, Brisbane, Australia). For the seven days prior to knee brace immobilisaton, participants will be provided a diet to achieve expected energy balance as calculated by the Schofield equation with an activity factor of 1.5. Macronutrient contributions will be ~17/66/17% for protein, carbohydrate and fat, respectively; protein will be clamped at 1.4-1.5 g/kg. At the commencement of the immobilisation period, an energy deficit of 30% (based on Schofield equation and activity factor of 1.5) will be implemented by reducing carbohydrate (primarily) and fat intake; protein will remain clamped at 1.4-1.5 g/kg. The resulting macronutrient contributions will be ~23/57/20% for protein, carbohydrate and fat, respectively, Adherence to diet will be monitored via daily food diaries that require participants to check off all foods consumed. Adherence to immobilisation will be monitored through actigraph accelerometers to determine physical activity levels and a unique identifier tape wrapped around to the brace will determine if/when a brace is removed. Muscle biopsies will be obtained on day 0, 3 and 14.
Intervention code [1] 298713 0
Treatment: Other
Intervention code [2] 299233 0
Treatment: Devices
Comparator / control treatment
A control group will be obtained from a prior study conducted in our laboratory that completed the same immobilisation intervention (14 days) in energy balance (Schofield equation with an activity factor of 1.5). The data collection period of the prior study was between 17/10/2016 and 1/7/2017 (ACTRN12616001399482).
Control group
Historical

Outcomes
Primary outcome [1] 302875 0
Changes in quadriceps muscle mass quantified by MRI and DEXA scans
Timepoint [1] 302875 0
Baseline (Day 0), and day 14 measurements
Primary outcome [2] 302876 0
Muscle biopsy analysis will be undertaken to better understand RNA/protein changes in muscle tissue samples due to immobilisation induced atrophy in combination with energy restriction. A non-specific global analysis of changes in RNA expression will be conducted.
Timepoint [2] 302876 0
Baseline (day 0), day 3 and day 14
Secondary outcome [1] 337285 0
Change in muscle strength as determined by isotonic testing. 3 repetition maximum load will be measured in the immobilised and non-immobilised legs on a unilateral leg press, and plate loaded leg extension and leg-curl machines.
Timepoint [1] 337285 0
Baseline (pre-immobilisation), and day 15 (one day post-immobilisation)

Eligibility
Key inclusion criteria
Physically active individuals undertaking ~4 exercise sessions per week of moderate-vigorous exercise.
Minimum age
20 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent (<6 months) injury requiring immobilsation, medical conditions that would place participants at increased risk during resistance exercise (strength testing), currently taking medications known to affect body composition, dietary allergies, employment requiring physical labour.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Repeated measures mixed ANOVA and other appropriate analysis of molecular results

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2017
Actual
Date of last participant enrolment
Anticipated
29/01/2018
Actual
Date of last data collection
Anticipated
16/02/2018
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297095 0
University
Name [1] 297095 0
Bond University
Country [1] 297095 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, ROBINA QLD 4226, AUSTRALIA.
Country
Australia
Secondary sponsor category [1] 296104 0
None
Name [1] 296104 0
Address [1] 296104 0
Country [1] 296104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298273 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 298273 0
Ethics committee country [1] 298273 0
Australia
Date submitted for ethics approval [1] 298273 0
09/06/2017
Approval date [1] 298273 0
19/07/2017
Ethics approval number [1] 298273 0
0000016052

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76554 0
Dr Thomas Doering
Address 76554 0
Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.
Country 76554 0
Australia
Phone 76554 0
+61 7 5595 0178
Fax 76554 0
Email 76554 0
[email protected]
Contact person for public queries
Name 76555 0
Thomas Doering
Address 76555 0
Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.
Country 76555 0
Australia
Phone 76555 0
+61 7 5595 0178
Fax 76555 0
Email 76555 0
[email protected]
Contact person for scientific queries
Name 76556 0
Thomas Doering
Address 76556 0
Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.
Country 76556 0
Australia
Phone 76556 0
+61 7 5595 0178
Fax 76556 0
Email 76556 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.