None listed
Conditions
Brief summary
This research project will investigate the effect of a dairy-derived nutritional supplement on physical health, mobility and well-being when combined with a physical activity program in 45-65 year-old women identified as habitually sedentary. The project has been designed to determine whether supplementation augments the positive response to a healthy lifestyle that includes moderate-level physical activity, and therefore whether supplementation is a beneficial addition to a healthy, active lifestyle. This is a 4-month randomised controlled trial in which 240 healthy, sedentary women will be randomised to receive: 1) a Fortified Milk Product (FMP) containing addition protein, vitamin D and calcium or a Non-Fortified drink (NFD). All women will also be asked to undertake a supervised gym-based exercise program twice a week under the supervision of accredited exercise trainers and one home-based training session. The multimodal exercise program will consist of strength, mobility and balance/functional training. Participants will undergo testing at baseline and after completion of the intervention (week 16) in the clinical lab at Deakin University. The main outcome for the study is functional muscle power, Secondary outcomes include: muscle strength, function, mobility and balance, body composition, cardiovascular health (blood pressure), circulating bone, cartilage, inflammatory and hormonal markers and perceptions of health, Dietary and physical activity habits will also be assessed. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the prevention (and management) of age-related loss in muscle health and function in sedentary middle-aged adults, along with the ongoing refinement of community-based initiatives for the management of these age-related changes.
Interventions
This is a 4-month community-based randomised controlled trial in which sedentary women aged 45-65 years will participate in a multi-modal exercise program involving progressive resistance training and functional balance/mobility activities and be randomised to receive either: 1) a milk-based fortified supplement (powder dissolved in water) or 2) a milk-based non-fortified energy matched drink/powder (dissolved in water). The fortified milk product (FMP, 30 g dose, 2x per day at breakfast and lun
This is a 4-month community-based randomised controlled trial in which sedentary women aged 45-65 years will participate in a multi-modal exercise program involving progressive resistance training and functional balance/mobility activities and be randomised to receive either: 1) a milk-based fortified supplement (powder dissolved in water) or 2) a milk-based non-fortified energy matched drink/powder (dissolved in water). The fortified milk product (FMP, 30 g dose, 2x per day at breakfast and lunch or within 1-2 hours of each exercise session: total 60 g/d) is largely comprised of milk powder (skim and whole), vitamins, minerals, complex milk lipids, and a small amount of hydrolysed fish collagen. It also contains low levels of Vitamins B12, B6, E and C. Each drink will contain approximately 418 kJ, 9 g protein, 634 mg calcium, 7.5 ug vitamin D, 86 mg magnesium and 2 mg zinc. The exercise program will be run within community leisure centres, individually tailored and supervised by qualified trainers. All participants will train twice a week within the leisure centres (45-60 minutes each) and after week 5 will be asked to complete one additional home based training session per week (15-20 minutes). The training will target all major muscle groups and participants will perform 3 sets of 8-12 repetitions at a moderate to high intensity. Training will be made progressively more challenging by incorporating the principle of progressive overload. Training will be supervised by accredited exercise trainers. Participants in both groups will be asked to consume their supplemental drink daily, once with breakfast and once at lunch/dinner (and within 1-2 hours after the exercise sessions on the three training days). Exercise logs and completed exercise cards will be regularly checked by the trainers and will be used to monitor exercise adherence. Adherence to the supplemental drink will be monitored using a daily food calendar.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Relatively sedentary, healthy, community-dwelling women aged 45-65 years with a BMI 17-40 and not engaged in any regular physical activity over the past 6 months (>150 min/week), including resistance training >1 week.
Exclusion criteria
Participants will be excluded based on the following: 1) BMI <17 or >40kg/m2, 2) daily step count >7500 per day, or 7501-9000 with <9 daily hours of sedentary time, 3) Previous negative reaction or allergies to milk, dairy proteins, fish collagen, rice, soy lecithin, sweeteners (sucralose, Ace K), vanillin, vitamin D, calcium, magnesium or zinc, 4) Moderate or high level physical activity over the past 6 months (>150 minutes moderate-vigorous physical activity) , 5) Any sustained form of resistance or strength training or regular physical activity (>1 session per week) for either leisure or occupation in the past 12 months, 6) Calcium intake of > 900 mg/day, 7) Use of calcium fortified foods such as biscuits or juice, vitamin D and multivitamin supplements on a regular basis; use of anti-acids containing calcium on a regular basis; bone/joint supplements glucosamine and chondroitin; magnesium supplements (if unable to stop for 4 weeks prior to entering the trial) or protein supplements, 8) Self-reported diagnosed osteoporosis or any low-trauma fracture in the past 12 months, such as hip, spine or wrist fractures, 9) Any fixations (i.e. spine or femoral rods, hip replacements) that would limit participation in the exercise program, 10) Current use of oral hormone replacement therapy, or within previous 12 months, 11) Pregnant, planning to become pregnant, or currently breastfeeding, 12) Self-reported renal disease. [note: Glomerular filtration rate (eGRF) <45ml/min/ 1.73m2, 13) Regular (>3 times per week) anti-inflammatory use over the past 3 months (including aspirin, ibuprofen, omega 3 supplements/fish oils), 14) Rheumatoid arthritis, 15) Self-reported cardiovascular disease (CVD), including heart disease as indicated by the ESSA screening tool or peripheral vascular disease that would limit participation in an exercise program, 16) Current use of any diuretic medication, 17) Metabolic bone disease (including osteomalacia, osteogenesis imperfect and Paget’s disease); also current use of bisphosphonates or during 12 months prior, 18) Endocrine disorders (including hyper- or hypothyroidism (if unstable for past 3 months), parathyroid disease, diabetes mellitus and Cushing’s syndrome), 19) Current (or past 6 months) cancer (including cervical, ovarian, uterine, breast, liver and of the gastrointestinal system), 20) Other medical conditions impacting on digestion, including diseases of the GI tract (eg. Crohn’s Disease, Ulcerative Colitis, Coeliac), or previous bariatric surgery, or liver cirrhosis, 21) Any chronic muscle disease, disorder or injury, not ambulatory, or any injury that would limit participation in the exercise program, 22) Asthma that is not controlled, or other chronic respiratory disease, 26) currently participating in a weight loss program, 27) Failure to obtain GP consent to exercise for those identified using the ESSA Adult Pre-Exercise Screening Tool.
Outcome results
None listed