ACTRN12617000383369Completed未知
Effects of a dairy-derived nutrition supplement combined with physical activity on health and physical function in 45-65 year old habitually sedentary women
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Deakin University
- Enrollment
- 244
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (—)
- Sex
- Female
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.
Investigators
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