Trial from ANZCTR


Trial ID ACTRN12610000821099
Trial Status: Registered
Date Submitted: 29/09/2010
Date Registered: 30/09/2010
Prospectively registered

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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.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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Secondary ID [1] 252611 0
none
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UTN U1111-1115-1700
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Trial acronym
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Health condition(s) or problem(s) studied:
Loss of muscle mass and strength in aging. 257474 0
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Prevention of sarcopenia. 258106 0
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Condition category: Condition code:
Musculoskeletal Other muscular and skeletal disorders
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Descriptions 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).
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Intervention Code:
Prevention 256570 0
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Intervention Code:
Other interventions 257320 0
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Lifestyle 257321 0
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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).
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Control group Placebo
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Primary Outcome: 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. 259131 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 259131 0
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Secondary Outcome: 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 265448 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265448 0
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Secondary Outcome: 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). 265449 0
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Timepoint: There are 2 timepoints, screening (week -1) and at the end of the intervention at Week 12. 265449 0
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Secondary Outcome: 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. 265450 0
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Timepoint: There are 2 timepoints, screening (week -1) and at the end of the intervention at Week 12. 265450 0
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Secondary Outcome: 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). 265451 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265451 0
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Secondary Outcome: To determine dose-response effect of NatraGuard compared to placebo on safety and tolerability 265452 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265452 0
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Secondary Outcome: 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) 265453 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265453 0
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Secondary Outcome: To determine dose-response effect of NatraGuard compared to placebo on change in cognitive function, assessed using the Rey Auditory Verbal Learning test (RAVLT) 265454 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265454 0
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Secondary Outcome: 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 265455 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265455 0
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Secondary Outcome: 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 265456 0
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Timepoint: There are 2 timepoints, baseline (week 0) and at the end of the intervention at Week 12. 265456 0
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Secondary Outcome: To determine dose-response effect of NatraGuard compared to placebo on Pharmacokinetic measurements at in a sub-group of up to 40 participants. 265457 0
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Timepoint: There are 5 timepoints - pre-dose and then 30 minutes, 1 hour, 2 hours and 3 hours post dose 265457 0
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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
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Minimum age 50 Years
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Maximum age 70 Years
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Gender Females
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Healthy volunteers? Yes
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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
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 1/11/2010
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Date of first participant enrolment 7/03/2011
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 30/03/2012
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Target sample size 160
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 257573 0
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Name: MG Nutritionals - a Division of Murray Goulbourn Co-op Co Ltd 257573 0
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Address: Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006 257573 0
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Country: Australia 257573 0
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Funding Source: Government body 257574 0
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Name: Victoria's Science Agenda (VSA) Investment Fund 257574 0
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Address: 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
257574 0
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Country: Australia 257574 0
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Funding Source: Charities/Societies/Foundations 257575 0
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Name: Gardiner Foundation Grant 257575 0
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Address: Geoffrey Gardiner Dairy Foundation Limited
Level 5
84 William Street
Melbourne VIC 3000
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Country: Australia 257575 0
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Primary Sponsor Commercial sector/Industry
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Name: MG Nutritionals - a Division of Murray Goulburn Co-op. Co. Ltd
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Address: Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006
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Country: Australia
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Secondary Sponsor: None 256795 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of South Australia Human Research Ethics Committee 259595 0
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Address: General Purpose Building, Mawson Lakes Campus, Mawson Lakes Boulevard
Mawson Lakes, SA 5095
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Country: Australia 259595 0
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Approval Date: 23/09/2010 259595 0
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Submitted Date: 259595 0
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HREC: P0000020969 259595 0
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Ethics Committee name: Barwon Health Human Research and Ethics Committee 259596 0
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Address: Barwon Health
PO Box 281
Geelong, VIC 3220
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Country: Australia 259596 0
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Approval Date: 259596 0
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Submitted Date: 259596 0
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HREC: 10/40 259596 0
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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.
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Trial website
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Principal Investigator
Title: Prof
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Name: Jonathan Buckley
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Address: University of South Australia, GPO Box 2471, Adelaide SA 5001
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Country: Australia
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Tel: +61883021853
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Email: jon.buckley@unisa.edu.au
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Contact person for public queries
Title: Mr
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Name: Justin Irvine
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Address: Freshwater Place, Level 15, 2 Southbank Boulevard, Southbank VIC 3006
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Country: Australia
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Tel: +61 3 9040 5000
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Fax: +61-3-99190841
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Email: justin.irvine@mgc.com.au
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Contact person for scientific queries
Title: Dr
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Name: Dr Andrew Brown
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Address: 90 Broadway St or PO Box 204 Cobram Vic 3644
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Country: Australia
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Tel: +61 3 5871 0361
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Fax: +61 3 5871 0339
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Email: andrew.brown@mgc.com.au
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Contact person responsible for updating information
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Name: Dr Andrew Brown
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Addition Cancer fields
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