ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Skeletal muscle atrophy

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

Treatment: Other

Intervention code [2]

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]

Changes in quadriceps muscle mass quantified by MRI and DEXA scans

Timepoint [1]

Baseline (Day 0), and day 14 measurements

Primary outcome [2]

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]

Baseline (day 0), day 3 and day 14

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Bond University

Address [1]

14 University Drive, ROBINA QLD 4226, AUSTRALIA.

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

14 University Drive, ROBINA QLD 4226, AUSTRALIA.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

Bond University
University Drive, Robina
Gold Coast, QLD 4226

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/06/2017

Approval date [1]

19/07/2017

Ethics approval number [1]

0000016052

Summary

Brief summary

The nature of training and competition in the majority of popular sports dictates that debilitating injury is not uncommon when individuals engage in high musculoskeletal loading patterns and/or high impact collisions. A consequence of such injuries is that repair and remodelling of tissues and joints often requires significant periods of limb immobilisation. During immobilisation a reduction in the normal mechanical loading of skeletal muscle results in muscle wasting (atrophy).

A challenge for individuals during periods of reduced physical activity (e.g. bed rest) or immobilisation is the management of body composition. The muscle unloading interaction with dietary intake has the capacity to modulate the effects of immobilisation on mechanisms regulating skeletal muscle mass. We (Areta et al. 2014) and others (Pasiakos et al. 2013) have shown that reduced total energy intake (30-40% below energy balance requirements) decreases muscle protein synthesis and results in a loss of fat mass but also muscle mass. However, higher protein intakes (>1.6 g/kg) during energy deficit may attenuate losses in lean mass (Pasiakos et al. 2013), despite an increased expression of genes associated with muscle protein breakdown (Carbone et al. 2013). How these dietary-muscle protein interactions change during periods of immobilisation is unknown.

Decreased energy expenditure from cessation of physical activity with immobilisation necessitates restriction of energy intake to prevent undesirable gains in fat mass. However, whether implementing an energy deficit, despite higher protein intakes, exacerbates muscle wasting experienced during muscle unloading is unknown. Importantly, the effect of an energy deficit on the magnitude of muscle loss and the associated underlying molecular profile during immobilisation is currently unknown.

The aim of this study is to determine changes in inducible gene/protein expression and skeletal muscle mass in the acute (3 d) and early (14 d) immobilisation period while under a moderate (30%) energy restriction with sufficient protein intake (1.4-1.5 g/kg). We will compare the effect of this energy deficit on muscle mass with immobilised participants in energy balance, a study previously completed in our laboratory. We hypothesize that 14 d of limb immobilisation with energy deficit will result in greater losses of total body fat, immobilised limb mass and gene expression for protein breakdown compared to immobilised limbs in energy balance.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Thomas Doering

Address

Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.

Country

Australia

Phone

+61 7 5595 0178

Fax

tdoering@bond.edu.au

Contact person for public queries

Name

Thomas Doering

Address

Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.

Country

Australia

Phone

+61 7 5595 0178

Fax

tdoering@bond.edu.au

Contact person for scientific queries

Name

Thomas Doering

Address

Bond Institute of Health and Sport, Bond University, 2 Promethean Way, Robina, QLD 4226 Australia.

Country

Australia

Phone

+61 7 5595 0178

Fax

tdoering@bond.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically