Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001375549
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
17/12/2015
Date last updated
26/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dairy protein on muscle protein synthesis at rest and after exercise
Scientific title
The effects of dairy protein on muscle protein synthesis at rest and after acute resistance exercise in middle aged men
Secondary ID [1] 288140 0
None
Universal Trial Number (UTN)
U1111-1172-8463
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle loss 297050 0
Condition category
Condition code
Musculoskeletal 297276 297276 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consumption of a formulated milk beverage containing 9 grams of dairy protein, 13g of carbohydrate and 3.2 g of lipid dissolved in 200 ml of water. Energy =504kJ

At baseline all participants will undergo DXA and pqCT scans to estimate body composition on muscle size as well as isometric strength measurements.. Participants will undergo a primed constant infusion of 13C6 phenylalanine for three hours in the rested fasted state before a muscle biopsy will be obtained from the vastus lateralis to calculate muscle protein synthesis (MPS). They will then preform 3 sets of unilateral knee extension and leg press for a randomly selected leg. They will then consume either the treatment or placebo beverage. Additional biopsies will be obtained from each leg at 90 and 210 min after beverage consumption while the isotope infusion is maintained. MPS will be calculated form 0-90 and 9-210 min after beverage consumption. .
Intervention code [1] 293451 0
Prevention
Intervention code [2] 293452 0
Lifestyle
Comparator / control treatment
Consumption of a beverage containing 28g of carbohydrate and 0 .6 g of lipid dissolved in 200 ml of water. Energy =491kJ.
Control group
Placebo

Outcomes
Primary outcome [1] 296856 0
Muscle protein synthesis in rested and post exercise states. A primed consistant infusion of 13C6 Phenylalanine will be combined with arterialized blood samples and muscle biopsies to calculate the fractional synthetic rate.
Timepoint [1] 296856 0
0-90 minutes after beverage consumption, 90 to 210 min after beverage consumption
Secondary outcome [1] 319541 0
Plasma amino acid concentrations
Timepoint [1] 319541 0
0, 15, 30, 45, 60,75,90,120,150,180 and 210 min after beverage consumption
Secondary outcome [2] 319542 0
Isometric knee extension strength
Timepoint [2] 319542 0
prior to beverage consumption
Secondary outcome [3] 319543 0
Body composition measured by DXA
Timepoint [3] 319543 0
Prior to beverage consumption
Secondary outcome [4] 319544 0
Thigh muscle size measured by pqCT
Timepoint [4] 319544 0
prior to beverage consumption

Eligibility
Key inclusion criteria
BMI (18-30kg/m2)
Sedentary to moderately active
Minimum age
35 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Diabetes or symptoms of metabolic syndrome or current pharmaceutical therapy

2. Other medical conditions impacting on digestion, including diseases of the gastrointestinal tract, allergy to dairy protein and history (or medical management) of mental illness

4. Smoking

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Participants will be randomized to consume either the treatment or placebo. Their legs will then be randomized so that one remains rested while the other will undergo resistance exercise.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Three way ANOVA with treatment, time and exercise as factors. Sample size was estimated based on a power of 80% and and alpha of 5%. A standardized effect size of 1.3 was estimated from previous unpublished work comparing the effects of 6 and 10 grams of dairy protein on muscle protein synthesis in middle aged men.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2016
Actual
9/02/2016
Date of last participant enrolment
Anticipated
31/03/2016
Actual
26/04/2016
Date of last data collection
Anticipated
Actual
4/05/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7415 0
New Zealand
State/province [1] 7415 0

Funding & Sponsors
Funding source category [1] 292548 0
Commercial sector/Industry
Name [1] 292548 0
Fonterra Co-operative Group Ltd
Country [1] 292548 0
New Zealand
Primary sponsor type
Individual
Name
David Cameron-Smith
Address
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 291267 0
University
Name [1] 291267 0
University of Auckland
Address [1] 291267 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country [1] 291267 0
New Zealand
Secondary sponsor category [2] 291292 0
University
Name [2] 291292 0
Fonterra Co-operative Group Ltd
Address [2] 291292 0
Fonterra Centre
9 Princes Street
Private Bag 92032
Auckland 1010
Country [2] 291292 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294025 0
Health and Disability Ethics Committees (Northern B)
Ethics committee address [1] 294025 0
Ethics committee country [1] 294025 0
New Zealand
Date submitted for ethics approval [1] 294025 0
18/08/2015
Approval date [1] 294025 0
14/12/2015
Ethics approval number [1] 294025 0
15/NTB/154

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

Contacts
Principal investigator
Name 62178 0
Prof David Cameron-Smith
Address 62178 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 62178 0
New Zealand
Phone 62178 0
+64 9 923 1336
Fax 62178 0
Email 62178 0
[email protected]
Contact person for public queries
Name 62179 0
Cameron Mitchell
Address 62179 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 62179 0
New Zealand
Phone 62179 0
+64 9 923 6606
Fax 62179 0
Email 62179 0
[email protected]
Contact person for scientific queries
Name 62180 0
Cameron Mitchell
Address 62180 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 62180 0
New Zealand
Phone 62180 0
+64 9 923 6606
Fax 62180 0
Email 62180 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
Dimensions AIMinimal dose of milk protein concentrate to enhance the anabolic signalling response to a single bout of resistance exercise; a randomised controlled trial2017https://doi.org/10.1186/s12970-017-0175-x
N.B. These documents automatically identified may not have been verified by the study sponsor.