None listed
Conditions
Brief summary
The aim of this randomised controlled trial is to investigate whether milk fortified with calcium and vitamin D3 combined with high intensity resistance training and weight-bearing impact exercise can lead to a greater effect on BMD at loaded sites than the sum of each factor alone in community-dwelling men aged over 50 years. It is hypothesized that the combination of exercise + calcium-vitamin D fortified milk will lead to greater gains in bone density at the hip than either exercise or calcium-vitamin D alone. This is an 18-month factorial design intervention with a 12-month follow up in which men will be randomised to one of four groups: (1) exercise + fortified milk; (2) exercise alone; (3) fortified milk alone; or (4) a usual control group. The primary outcome is femoral neck bone mineral density. Secondary aims (outcomes) are to: 1) evaluate the effects of the intervention on DXA total hip and lumbar spine BMD, QCT bone density, structure and strength at the spine, femur and tibia, body composition (lean and fat mass and muscle size), muscle strength and function, blood pressure and blood lipids, inflammatory and bone turnover markers, health related quality of life and mood, and 2) evaluate the long-term residual effects (12 months post intervention). The results from this trial will provide important information as to whether food-based nutritional supplementation (calcium-vitamin D enriched milk) can enhance the effects of exercise on musculoskeletal health and function in older men with normal to low bone density.
Interventions
This is an 18-month factorial 2x2 design randomised controlled trial (with a 12 month follow-up) in which community dwelling men aged 50+ years will be randomly allocated to one of four groups: 1) exercise + calcium-vitamin D fortified milk; (2) exercise alone; (3) calcium-vitamin D fortified milk alone; or (4) a usual care control group. Men randomised to the exercise program will be asked to train three times per week (60 minutes per session) and complete a program consisting of moderate to h
This is an 18-month factorial 2x2 design randomised controlled trial (with a 12 month follow-up) in which community dwelling men aged 50+ years will be randomly allocated to one of four groups: 1) exercise + calcium-vitamin D fortified milk; (2) exercise alone; (3) calcium-vitamin D fortified milk alone; or (4) a usual care control group. Men randomised to the exercise program will be asked to train three times per week (60 minutes per session) and complete a program consisting of moderate to high intensity (60 - 85% of maximum strength) progressive resistance training (PRT) and multidirectional moderate to high impact weight-bearing activities (eg. jumping, hopping). For the first 12 months the exercises will be performed in a slow and controlled manner and for the final 6-months the program will focus on high velocity resistance training (rapid concentric muscle contractions). The exercise program will be run within community leisure centres, individually tailored and supervised by qualified trainers. Exercise logs and completed exercise cards will be regularly checked by the trainers and will be used to monitor exercise adherence. For men allocated to the calcium-vitamin D fortified milk, they will be asked to consume 400 mls/d (2 x 200 ml tetra packs) of reduced fat (1%) ultra-high temperature milk each day. Each 200 ml milk tetra pack will contain approximately 500 mg calcium, 400 IU vitamin D3, 418 kJ energy, 6.6g protein, 2.2 g fat, 11 g lactose, 100 mg sodium and 250 mg phosphorus. Adherence to the milk drink will be monitored using a daily food calendar.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Community dwelling men aged 50+ years with normal to below average hip or femoral neck bone density (T-score between +0.4 to -2.4 SD).
Exclusion criteria
Use of calcium and/or vitamin D supplements within the past 12 moths, participation in resistance training and/or high-impact weight bearing activities for greater 30 minutes three times per week in the preceding 6 months; BMI of >35 kg/m2; history of osteoporotic fracture or any medical condition or medication use known to affect bone metabolism; lactose intolerant; consumed more than four standard alcoholic drinks per day; current smokers, or any chronic condition that might limit their ability to be involved in the intervention.
Outcome results
None listed