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.

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000821099

Enrollment

160

Registered

2010-09-30

Start date

2011-03-07

Completion date

2012-03-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Nat

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

50 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

overweight postmenopausal women currently participating in regular physical activity 2-3 times per week, but not under supervision of a personal trainer

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

Outcome results