ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000454572

Ethics application status

Approved

Date submitted

22/04/2015

Date registered

11/05/2015

Date last updated

13/04/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of dairy supplementation during immobilization on muscle loss in healthy adult males.

Scientific title

The efficacy of milk protein in reducing muscle loss during immobilization in healthy adult males

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1160-3655

Trial acronym

Linked study record

Health condition

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

immobilization induced muscle loss

Sarcopenia

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention period is 7 weeks.
Daily dose of 20g of milk protein concentrate consumed in 200ml of water. subjects will log the consumption of their supplement. during the entire study
subjects will be provided with breakfast and dinner daily and a nutritionist will give advice on lunch foods to ensure they are consuming 1.0g/kg/day of protein exclusive of the supplement.
During the first week of the study subject's diets will be controlled but they will not consume the supplement or placebo. During the following two weeks they will undergo unilateral lower limb immobilization using a knee brace and will consume the supplement or placebo. During the next two weeks the brace will be removed and they will be asked to take 10,000 steps per day which will be tracked by an accelerometer, they will continue with the supplement or placebo. For the final two weeks of the study subjects will continue to take 10,000 steps per day and will also complete a total of 6 lower body resistance training sessions. Training session will take approximately 30 min in consist of 4 sets preformed to fatigue at 80% of estimated one repetition maximum for both the leg press and leg extension exercise. each session will be supervised at a one-one ratio with a trained investigator. They will continue with the supplement or placebo.

Intervention code [1]

Prevention

Comparator / control treatment

Daily dose of 20g of carbohydrate placebo contained maltodextrin and lactose. The powder is dissolved in 200 ml of water and has a slight vanilla flavour to match that of the protein supplement.

Control group

Placebo

Outcomes

Primary outcome [1]

mid thigh muscle cross sectional area by pqCT scan

Timepoint [1]

baseline (week 0)
post baseline period (+1 week)
Post immobilization (+3 weeks)
post healthy living (+5 weeks)
post resistance training (+7 weeks)

Primary outcome [2]

Knee extension torque at 90 degrees measured by dynamometer

Timepoint [2]

baseline (week 0)
post baseline period (+1 week)
Post immobilization (+3 weeks)
post healthy living (+5 weeks)
post resistance training (+7 weeks)

Secondary outcome [1]

single leg maximal aerobic power by single leg cycle test of power output

Timepoint [1]

baseline (week 0)
post baseline period (+1 week)
Post immobilization (+3 weeks)
post healthy living (+5 weeks)
post resistance training (+7 weeks)

Secondary outcome [2]

Single leg vertical jump

Timepoint [2]

baseline (week 0)
post baseline period (+1 week)
Post immobilization (+3 weeks)
post healthy living (+5 weeks)
post resistance training (+7 weeks)

Secondary outcome [3]

muscle protein synthesis measured by muscle deuterium enrichment

Timepoint [3]

post baseline period (+1 week)
Post immobilization (+3 weeks)
post healthy living (+5 weeks)
post resistance training (+7 weeks)

Eligibility

Key inclusion criteria

non smoker
healthy
BMI 18-34

Minimum age

45 Years

Maximum age

60 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

current smoking
BMI >34
currently taking beta blockers
currently taking statin drugs
history of DVT
history of lower body musculoskeletal problems

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Assigned subject number based on the date of enrolment in the trial. Allocation is concealed using locked spreadsheet which only reveals allocation once a subject's name and dominant leg has been entered.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

random sequence generated by http://www.r-project.org/

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Immobilization leg is randomized to dominant or non dominant based in a counterbalanced fashions

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Two way RM ANOVAs

The study was powered based 20% +/- 5% decease in knee extension torque following immobilization and was powered to find a 50% attenuation of muscle torque loss. 80% power was used and alpha was set at 0.05. This resulted in a subject number of 15 per group.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/02/2015

Actual

26/02/2015

Date of last participant enrolment

Anticipated

1/09/2015

Actual

9/06/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fonterra

Address [1]

9 Princes Street, Auckland 1010

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Fonterra

Address

9 Princes Street, Auckland 1010

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland

Address [1]

The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

09/10/2014

Approval date [1]

16/10/2014

Ethics approval number [1]

14/NTA/146/AM01

Summary

Brief summary

all subjects complete a 7 week protocol with a dietary intake 1.0g/kg/day of protein. The subjects are free living for the first week, undergo unilateral lower limb immobilization for the following two weeks. the next two weeks subjects are remobilized and encouraged to take 10,000 steps per day. for the final two weeks subjects preform resistance training thrice weekly. subjects are randomized to consume 20g of milk protein or placebo dairying following the free living phase. 

The purpose of this study is to determine if supplemental protein can attenuate muscle and strength loss during immobilization or enhance the degree of muscle and strength regain.

It is hypothesized that supplemental protein will reduce the degree of muscle and strength loss during immobilization and enhance the rate of muscle and strength recovery.

Trial website

http://hnu.auckland.ac.nz/nutrition-mobility

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Cameron-Smith

Address

Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

64 9 923 1336

Fax

d.cameron-smith@auckland.ac.nz

Contact person for public queries

Name

Cameron MItchell

Address

Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64099236606

Fax

cameron.mitchell@auckland.ac.nz

Contact person for scientific queries

Name

Cameron Mitchell

Address

Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64099236606

Fax

cameron.mitchell@auckland.ac.nz

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

Source	Title	Year of Publication	DOI
Dimensions AI	Impact of dairy protein during limb immobilization and recovery on muscle size and protein synthesis; a randomized controlled trial	2017	https://doi.org/10.1152/japplphysiol.00803.2017
Embase	Daily protein supplementation attenuates immobilization-induced blunting of postabsorptive muscle mTORC1 activation in middle-aged men.	2021	https://dx.doi.org/10.1152/ajpcell.00284.2020
Embase	Ribosome biogenesis and degradation regulate translational capacity during muscle disuse and reloading.	2021	https://dx.doi.org/10.1002/jcsm.12636

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically