Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000393358
Ethics application status
Approved
Date submitted
14/03/2017
Date registered
16/03/2017
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of three different dairy protein beverages on muscle protein synthesis after exercise
Scientific title
The effects of three different dairyprotein fractions on muscle anabolism after resistance exercise in young healthy men
Secondary ID [1] 290926 0
None
Universal Trial Number (UTN)
U1111-1194-2489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle loss 301650 0
Condition category
Condition code
Musculoskeletal 301361 301361 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consumption of the proprietary milk protein concentrate (pMPC) containing 25.0g of dairy protein, 1.3g of carbohydrate and 0.5g of fat dissolved in 200mL of water. Energy = 458kJ.

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 consume a standardised meal (60% carbohydrate, 20% protein and 20% fat) the night before the trial and must be in an overnight fasted state when arriving at the CRU by 0800h. A muscle biopsy will be taken after a 30 minute rest, and then followed by a blood sample. The participants will then undergo a primed constant infusion of 13C6 phenylalanine (prime: 2 micromol kg-1; infusion: 0.05 micromol kg-1 min-1) for the rest of the trial duration. Blood samples will be taken again every hour for the next three hours. Immediate after the third blood sample a second muscle biopsy from the contralateral leg will be obtained. The participant will then complete three sets of leg presses and leg extensions using both legs on commercial gym equipment. Each set will be at a load of 80% of 1RM and repetitions will be preformed until the point of momentary muscle fatigue. Two minutes of rest will be taken between each set and exercise. all exercise will be supervised by a trained investigator. The total duration of the exercise will be approximately 20 minutes. Immediately after exercise they will consume one of three protein beverages. Beverage consumption will take place within 5 minutes and will be supervised by an investigator in order to ensure compliance. Several blood samples will be taken from the participant up to 240 min. Further muscle biopsies will be taken at 120 min and 240 min after beverage consumption.
Intervention code [1] 296867 0
Prevention
Intervention code [2] 296868 0
Lifestyle
Comparator / control treatment
Consumption of a beverage containing 25g standard milk protein concentrate or 25g casein dissolved in 200 mL of water. Energy = 532kJ and 455kJ respectively.
Control group
Active

Outcomes
Primary outcome [1] 300754 0
Muscle protein synthesis following resistance exercise. A primed consistent infusion of 13C6 phenylalanine will be combined with arterialized blood samples and muscle biopsies to calculate the fractional synthesis rate.
Timepoint [1] 300754 0
between 0 and 120 minutes after beverage consumption, and between 120 and 240 minutes after beverage consumption.
Secondary outcome [1] 330797 0
Plasma amino acid concentration.
Timepoint [1] 330797 0
0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 min after beverage consumption.
Secondary outcome [2] 332729 0
Muscle anabolic signalling measured using western blot.
Timepoint [2] 332729 0
2 and 4 hours post exercise
Secondary outcome [3] 332730 0
ribosomal subunit expression measured using quantitative real-time polymerase chain reaction
Timepoint [3] 332730 0
2 and 4 hours following exercise

Eligibility
Key inclusion criteria
BMI 18-30 kg/m2
Sedentary to moderately active
Minimum age
18 Years
Maximum age
35 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
3. any conditions impairing mobility, prior muscle damage, recent limb injury, burns, muscle wasting disorders
4. Smoking
5. Regular lower body resistance training in last 6 months
6. Any bleeding disorders

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 randomization using a randomization 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 one of three milk protein drinks. They will first perform leg resistance exercises and consume the drink immediately.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way ANOVA with time as a repeated factor and supplement as a between subject factor

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2017
Actual
8/04/2017
Date of last participant enrolment
Anticipated
Actual
9/06/2017
Date of last data collection
Anticipated
Actual
13/07/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 8576 0
New Zealand
State/province [1] 8576 0

Funding & Sponsors
Funding source category [1] 295354 0
Commercial sector/Industry
Name [1] 295354 0
Fonterra Co-operative Group Ltd
Country [1] 295354 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] 294178 0
University
Name [1] 294178 0
University of Auckland
Address [1] 294178 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country [1] 294178 0
New Zealand
Secondary sponsor category [2] 294179 0
Commercial sector/Industry
Name [2] 294179 0
Fonterra Co-operative Group Ltd
Address [2] 294179 0
Fonterra Centre
9 Princes Street
Private Bag 92032
Auckland 1010
Country [2] 294179 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296686 0
Health and Disability Ethics Committees (Northern B)
Ethics committee address [1] 296686 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296686 0
New Zealand
Date submitted for ethics approval [1] 296686 0
10/11/2016
Approval date [1] 296686 0
21/12/2016
Ethics approval number [1] 296686 0
16/CEN/206

Summary
Brief summary
Dairy protein is known to stimulate muscle protein synthesis (MPS) and resistance training is known have a synergistic effect to further increase MPS. When comparing the two milk proteins, whey and casein, whey seems to have a greater effect in stimulating MPS. However, normal dairy milk behaves similar to casein. This new milk protein concentrate developed by Fonterra Co-operative Group Ltd has been treated to act similar to whey, while the protein composition remains the same. We hypothesized that this new milk protein concentrate would stimulate MPS similar to whey protein when combined with resistance exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71754 0
Prof David Cameron-Smith
Address 71754 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 71754 0
New Zealand
Phone 71754 0
+64 9 923 1336
Fax 71754 0
Email 71754 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 71755 0
Dr Cameron Mitchell
Address 71755 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 71755 0
New Zealand
Phone 71755 0
+64 9 923 6606
Fax 71755 0
Email 71755 0
cameron.mitchell@auckland.ac.nz
Contact person for scientific queries
Name 71756 0
Dr Cameron Mitchell
Address 71756 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 71756 0
New Zealand
Phone 71756 0
+64 9 923 6606
Fax 71756 0
Email 71756 0
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
SourceTitleYear of PublicationDOI
EmbaseThe degree of aminoacidemia after dairy protein ingestion does not modulate the postexercise anabolic response in young men: A randomized controlled trial.2019https://dx.doi.org/10.1093/jn/nxz099
N.B. These documents automatically identified may not have been verified by the study sponsor.