None listed
Conditions
Brief summary
This is a randomised controlled study to evaluate the effects of daily 30 g whey protein supplementation on bone structure, muscle mass and strength, renal function, cardiovascular risk factors and body composition in women aged 70-80 years at baseline.
Interventions
A two-year randomised double-blind dietary intervention study of daily 30 g whey protein in the form of milk beverage drink versus placebo drink. All participants receive 600 mg calcium per day from the drink.
Sponsors
A Professor RL Prince
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
70 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Able to comply with the requirements of the protocol.
Exclusion criteria
• Participation in another clinical trial during the last 12 weeks • Previous osteoporotic fracture• Currently or within last year taking medication for osteoporosis apart from calcium or vitamin D • Taking steroid tablets (eg Cortisone) in the past 3 months or have taken more than 7 g in total• Metabolic bone disease apart from osteoporosis• Total hip bone density more than 2SD below the mean for their age• Lactose intolerance or do not like milk products• High protein intake (more than 1.5 g/kg body weight per day)• Cognitive impairment (Mini Mental Sate score < 24)• Body mass index > 35 kg/cm2• Bowel surgery or difficulty absorbing food • Coeliac disease• Hepatic insufficiency or renal insufficiency • Participants who, in the opinion of the investigator are not likely to complete the study for any reason.
Outcome results
None listed