Trial registered on ANZCTR


Trial ID
ACTRN12610000821099
Ethics application status
Approved
Date submitted
29/09/2010
Date registered
30/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of NatraGuard(trademark), a novel cow's milk protein isolate, on muscle strength and body composition of postmenopausal women undertaking an exercise program.
Scientific title
A Phase II, multi-centre, 12-week, randomised, double-blind, placebo controlled, dose ranging study of the efficacy and safety of NatraGuard(trademark) (a bovine whey protein isolate) in postmenopausal women undertaking a combination of aerobic and resistance exercise training programs for the improvement of muscle strength and body composition.
Secondary ID [1] 252611 0
none
Universal Trial Number (UTN)
U1111-1115-1700
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Loss of muscle mass and strength in aging. 257474 0
Prevention of sarcopenia. 258106 0
Condition category
Condition code
Musculoskeletal 257623 257623 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake a 3 month exercise program of combined aerobic and resistance exercise training for five days per week, with resistance training being performed on 3 days and aerobic training on 2 days. Participants will also be required to consume a capsule containing a proprietary bovine milk protein isolate powder rich in growth factors (NatraGuard) combined with Bovine milk casein powder. They will be randomised to consume daily doses of 30mg NatraGuard + 270mg casein, 100mg NatraGuard + 200mg casein, 300mg NatraGuard, or 300mg casein (placebo).
Intervention code [1] 256570 0
Prevention
Intervention code [2] 257320 0
Other interventions
Intervention code [3] 257321 0
Lifestyle
Comparator / control treatment
Participants will undertake a program of combined aerobic and resistance exercise training for five days per week, with resistance training being performed on 3 days and aerobic training on 2 days. The control group will be required to consume a capsule containing only Bovine milk casein powder (300mg casein).
Control group
Placebo

Outcomes
Primary outcome [1] 259131 0
The primary objective of the study is to determine, over 12 weeks, the dose-response effects of NatraGuard compared to placebo, on change in isometric knee extensor muscle strength quantified using an isokinetic dynamometer, in postmenopausal female participants undertaking a program of combined aerobic and resistance exercise training.
Timepoint [1] 259131 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [1] 265448 0
To determine dose-response effect of NatraGuard compared to placebo on change in 8 repetition maximum of bench press, lateral pull down, leg press, knee extension and leg curl
Timepoint [1] 265448 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [2] 265449 0
To determine dose-response effect of NatraGuard compared to placebo on change in whole body lean mass and fat mass quantified by dual energy X-ray absorptiometry (DXA).
Timepoint [2] 265449 0
There are 2 timepoints, screening (week -1) and at the end of the intervention at Week 12.
Secondary outcome [3] 265450 0
To determine dose-response effect of NatraGuard compared to placebo on change in bone mineral density (BMD) and bone mineral content (BMC) at the lumbar spine and bilateral total hip.
Timepoint [3] 265450 0
There are 2 timepoints, screening (week -1) and at the end of the intervention at Week 12.
Secondary outcome [4] 265451 0
To determine dose-response effect of NatraGuard compared to placebo on change in the bone resorption marker plasma C-terminal telopeptide (CTX) and the bone formation marker plasma procollagen type 1 N-propeptide (P1NP).
Timepoint [4] 265451 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [5] 265452 0
To determine dose-response effect of NatraGuard compared to placebo on safety and tolerability
Timepoint [5] 265452 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [6] 265453 0
To determine dose-response effect of NatraGuard compared to placebo on change in cardiometabolic risk factors: body mass index, percentage body fat, sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP), waist circumference measured at the iliac crest, fasting blood glucose, insulin sensitivity (homeostasis model assessment -2, HOMA-2), plasma lipids (total cholesterol [TC], triglycerides [TG], high density lipoprotein cholesterol [HDL-C] & calculated low dentisy lipoprotein cholesterol [LDL-C]), plasma high sensitivity C-reactive protein (hsCRP)
Timepoint [6] 265453 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [7] 265454 0
To determine dose-response effect of NatraGuard compared to placebo on change in cognitive function, assessed using the Rey Auditory Verbal Learning test (RAVLT)
Timepoint [7] 265454 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [8] 265455 0
To determine dose-response effect of NatraGuard compared to placebo on change in health and well being assessed using the short form health survey (SF-12) questionnaire
Timepoint [8] 265455 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [9] 265456 0
To determine dose-response effect of NatraGuard compared to placebo on change in Visual Analogue Scale (VAS) to record muscle pain weekly throughout the study
Timepoint [9] 265456 0
There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12.
Secondary outcome [10] 265457 0
To determine dose-response effect of NatraGuard compared to placebo on Pharmacokinetic measurements at in a sub-group of up to 40 participants.
Timepoint [10] 265457 0
There are 5 timepoints - pre-dose and then 30 minutes, 1 hour, 2 hours and 3 hours post dose

Eligibility
Key inclusion criteria
overweight postmenopausal women currently participating in regular physical activity 2-3 times per week, but not under supervision of a personal trainer
Minimum age
50 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
lactose intolerance or allergy to cow's milk protein, current smoker or excess alcohol consumption, Diabetes, diagnosed osteoporosis or upper/lower extremity fracture in past 3 months, vitamin D deficiency, use of medications that affect bone or muscle metabolism, history of malignancy or elevated cancer markers at screening, elevated blood pressure

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)
Subjects will be recruited by newspaper advertisement and flyers. Volunteers will be screened via questionnaire and a medical screening visit to access their eligibility for the trial. Eligibility will be determined by the study coordinator and medical physician. Treatment will be randomly allocated and allocation is concealed with study investigational product bottles pre-labelled with individual randomisation numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The bottle numbers will be allocated to one of four treatment groups using a computer generated random allocation. Stratification will be used to ensure that the number of participants receiving each treatment is closely balanced within each study centre. Blocking will be used to ensure close balance of the treatment allocation at each study centre at any time during the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
1/11/2010
Actual date of first participant enrolment
7/03/2011
Anticipated date last participant enrolled
Actual date last participant enrolled
30/03/2012
Target sample size
160
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257573 0
Commercial sector/Industry
Name [1] 257573 0
MG Nutritionals - a Division of Murray Goulbourn Co-op Co Ltd
Address [1] 257573 0
Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006
Country [1] 257573 0
Australia
Funding source category [2] 257574 0
Government body
Name [2] 257574 0
Victoria's Science Agenda (VSA) Investment Fund
Address [2] 257574 0
VSA Investment Fund
Innovation and Technology Division
Department of Innovation, Industry and Regional Development
Level 35, 121 Exhibition Street
Melbourne, VIC 3000

GPO Box 4509
Melbourne, VIC 3001
Country [2] 257574 0
Australia
Funding source category [3] 257575 0
Charities/Societies/Foundations
Name [3] 257575 0
Gardiner Foundation Grant
Address [3] 257575 0
Geoffrey Gardiner Dairy Foundation Limited
Level 5
84 William Street
Melbourne VIC 3000
Country [3] 257575 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MG Nutritionals - a Division of Murray Goulburn Co-op. Co. Ltd
Address
Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006
Country
Australia
Secondary sponsor category [1] 256795 0
None
Name [1] 256795 0
Address [1] 256795 0
Country [1] 256795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259595 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 259595 0
General Purpose Building, Mawson Lakes Campus, Mawson Lakes Boulevard
Mawson Lakes, SA 5095
Ethics committee country [1] 259595 0
Australia
Date submitted for ethics approval [1] 259595 0
Approval date [1] 259595 0
23/09/2010
Ethics approval number [1] 259595 0
P0000020969
Ethics committee name [2] 259596 0
Barwon Health Human Research and Ethics Committee
Ethics committee address [2] 259596 0
Barwon Health
PO Box 281
Geelong, VIC 3220
Ethics committee country [2] 259596 0
Australia
Date submitted for ethics approval [2] 259596 0
Approval date [2] 259596 0
Ethics approval number [2] 259596 0
10/40

Summary
Brief summary
One of the most visible signs of ageing is the loss of muscle mass. This loss of muscle mass has subtle, yet significant, impacts on the health of an individual. Muscle provides the necessary tissue for physical activity, therefore a loss of muscle reduces physical capacity. With time, the loss of muscle mass, strength and coordination increases the risks of falls.

NatraGuard consists of proteins isolated from cow’s milk. Studies have been performed on muscle cells in the laboratory and in mouse models that demonstrate NatraGuard stimulates muscle cell growth and therefore may contribute to muscle strength.

The aim of this project is to determine, in participants undertaking aerobic and resistance training, the dose(s) of a dairy protein extract (NatraGuard) that produce improvement in muscle strength. This new knowledge will be used to design future research studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31229 0
Prof Jonathan Buckley
Address 31229 0
University of South Australia, GPO Box 2471, Adelaide SA 5001
Country 31229 0
Australia
Phone 31229 0
+61883021853
Fax 31229 0
Email 31229 0
jon.buckley@unisa.edu.au
Contact person for public queries
Name 14476 0
Mr Justin Irvine
Address 14476 0
Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006
Country 14476 0
Australia
Phone 14476 0
+61 3 9040 5000
Fax 14476 0
+61-3-99190841
Email 14476 0
justin.irvine@mgc.com.au
Contact person for scientific queries
Name 5404 0
Dr Dr Andrew Brown
Address 5404 0
90 Broadway St or PO Box 204
Cobram Vic 3644
Country 5404 0
Australia
Phone 5404 0
+61 3 5871 0361
Fax 5404 0
+61 3 5871 0339
Email 5404 0
andrew.brown@mgc.com.au