Trial Review

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
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] 286579 0
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 294840 0
Sarcopenia 294908 0
Condition category
Condition code
Musculoskeletal 295110 295110 0 0
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] 291693 0
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] 294873 0
mid thigh muscle cross sectional area by pqCT scan
Timepoint [1] 294873 0
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] 294874 0
Knee extension torque at 90 degrees measured by dynamometer
Timepoint [2] 294874 0
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] 314262 0
single leg maximal aerobic power by single leg cycle test of power output
Timepoint [1] 314262 0
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] 314263 0
Single leg vertical jump
Timepoint [2] 314263 0
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] 314356 0
muscle protein synthesis measured by muscle deuterium enrichment
Timepoint [3] 314356 0
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
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 6839 0
New Zealand
State/province [1] 6839 0
Auckland

Funding & Sponsors
Funding source category [1] 291138 0
Commercial sector/Industry
Name [1] 291138 0
Fonterra
Country [1] 291138 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra
Address
9 Princes Street, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 289817 0
University
Name [1] 289817 0
University of Auckland
Address [1] 289817 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country [1] 289817 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292715 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 292715 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292715 0
New Zealand
Date submitted for ethics approval [1] 292715 0
09/10/2014
Approval date [1] 292715 0
16/10/2014
Ethics approval number [1] 292715 0
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 56730 0
Prof David Cameron-Smith
Address 56730 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 56730 0
New Zealand
Phone 56730 0
64 9 923 1336
Fax 56730 0
Email 56730 0
[email protected]
Contact person for public queries
Name 56731 0
Dr Cameron MItchell
Address 56731 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 56731 0
New Zealand
Phone 56731 0
+64099236606
Fax 56731 0
Email 56731 0
[email protected]
Contact person for scientific queries
Name 56732 0
Dr Cameron Mitchell
Address 56732 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 56732 0
New Zealand
Phone 56732 0
+64099236606
Fax 56732 0
Email 56732 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
SourceTitleYear of PublicationDOI
EmbaseDaily protein supplementation attenuates immobilization-induced blunting of postabsorptive muscle mTORC1 activation in middle-aged men.2021https://dx.doi.org/10.1152/ajpcell.00284.2020
EmbaseRibosome biogenesis and degradation regulate translational capacity during muscle disuse and reloading.2021https://dx.doi.org/10.1002/jcsm.12636
Dimensions AIImpact of dairy protein during limb immobilization and recovery on muscle size and protein synthesis; a randomized controlled trial2017https://doi.org/10.1152/japplphysiol.00803.2017
N.B. These documents automatically identified may not have been verified by the study sponsor.