Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001100785
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
2/10/2013
Date last updated
2/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-Prandial Effects of Dairy Products in Middle-Aged Men
Scientific title
The effect of two novel dairy products versus two standard dairy products on muscle protein synthesis in middle-aged men
Secondary ID [1] 283334 0
none
Universal Trial Number (UTN)
U1111-1144-6166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 290206 0
Condition category
Condition code
Musculoskeletal 290599 290599 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume one of the six beverages on a single occasion only.
Arm 1 – 20 g standard milk protein concentrate (MPC1/20)
Arm 2 - 20 g novel milk protein concentrate (MPC2/20)
Arm 3 - 20 g standard whey protein concentrate (WPC1/20)
Arm 4 - 20 g novel whey protein concentrate (WPC2/20)
Arm 5 – 14 g standard milk protein concentrate (MPC2/14)
Arm 6 – 8 g standard milk protein concentrate (MPC2/8)
Intervention code [1] 288037 0
Prevention
Comparator / control treatment
Standard milk protein concentrate
Standard whey protein concentrate
Control group
Active

Outcomes
Primary outcome [1] 290609 0
Muscle protein synthesis determined based on a primed constant infusion of L-[ring-(13)C(6)]phenylalanine and L-[ring-(2)H(2)]tyrosine, in conjunction with repeated muscle biopsies.
Timepoint [1] 290609 0
At 90 min to 210 min after ingestion.
Primary outcome [2] 290610 0
Muscle metabolism biomarkers including microRNAs assessed by real-time qPCR in plasma and skeletal muscle.
Timepoint [2] 290610 0
At baseline, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 min after ingestion
Secondary outcome [1] 304902 0
Plasma amino acids assessed by HPLC.
Timepoint [1] 304902 0
At baseline, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 min after ingestion

Eligibility
Key inclusion criteria
Healthy
Male
45-60 yrs
BMI (18-30kg/m2)
Sedentary to moderately active
Minimum age
45 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetes or cardiovascular disease risk or current pharmaceutical therapy.
Other medical conditions impacting on digestion, including diseases of the gastrointestinal tract, allergy to dairy protein and history (or medical management) of mental illness.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 5446 0
New Zealand
State/province [1] 5446 0
Auckland

Funding & Sponsors
Funding source category [1] 288051 0
Commercial sector/Industry
Name [1] 288051 0
Fonterra Co-operative Group Ltd
Country [1] 288051 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group Ltd
Address
9 Princes Street, Private Bag 92032, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286776 0
None
Name [1] 286776 0
Address [1] 286776 0
Country [1] 286776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289976 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 289976 0
Health and Disability Ethics Committee, Ministry of Health, C/- MEDSAFE, Level 6, Deloitte House, 10 Brandon Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 289976 0
New Zealand
Date submitted for ethics approval [1] 289976 0
Approval date [1] 289976 0
12/08/2013
Ethics approval number [1] 289976 0
13/NTA/95

Summary
Brief summary
Aging is associated with a progressive loss of muscle mass and muscle function. Nutritional interventions which can help maintain muscle health during middle-age may improve quality of life in later years. The objective of the study is to evaluate the post-prandial effects of dairy products on muscle protein synthesis and muscle metabolism biomarkers. The study is a double-blind, randomized, controlled, parallel design. 48 healthy middle-aged males (45-60 yrs), BMI 18-30kg/m2 will be recruited, and muscle composition and muscle function tests conducted. After an overnight fast, subjects will consume one of six dairy beverages containing an equivalent content of 20g protein as standard milk protein concentrate (MPC1/20), 20g protein as propriety milk protein concentrate (MPC2/20), 20g protein as standard whey protein concentrate (WPC1/20), 20g protein as propriety whey protein concentrate (WPC2/20), 14g protein as propriety milk protein concentrate (MPC2/14) or 8g protein as propriety milk protein concentrate (MPC2/8). Muscle protein synthesis will be determined based on a primed constant infusion of L-[ring-(13)C(6)]phenylalanine and L-[ring-(2)H(2)]tyrosine. The primary end-points are muscle protein synthesis rate, plasma and muscle metabolism biomarkers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43334 0
Prof David Cameron-Smith
Address 43334 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43334 0
New Zealand
Phone 43334 0
+64 9 923 1336
Fax 43334 0
Email 43334 0
[email protected]
Contact person for public queries
Name 43335 0
Dr Robin A McGregor
Address 43335 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43335 0
New Zealand
Phone 43335 0
+64 9 630 1162
Fax 43335 0
Email 43335 0
[email protected]
Contact person for scientific queries
Name 43336 0
Prof Sally D Poppitt
Address 43336 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43336 0
New Zealand
Phone 43336 0
+64 9 630 5160
Fax 43336 0
Email 43336 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
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