Bone and Bones, Osteoporosis, Postmenopausal, Osteoporosis Risk
Conditions
Keywords
Osteoporosis, Postmenopausal, Bone Turnover Markers, Dairy Products
Brief summary
The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the life-cycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause). Bone turnover is a nutritionally modulated process and the investigators believe a milk-based protein supplement (MBPS) can modulate beneficially the rate of bone resorption over the time period when bone remodeling is most active i.e. late evening/overnight. In this novel approach to the timing of nutrient ingestion, the proposed nutrient intervention seeks to modify (reduce) the rate of bone resorption and promote the rate of bone formation to the benefit of bone health in this at risk population..
Detailed description
Study design: A block randomised, controlled study among healthy, post-menopausal women with osteopenia receiving a milk-based protein supplement (MBPS) in the evening, or not,(CONTROL) for a period of 24 weeks. Composition of MBPM - 25g of milk-based proteins + 1000mg dairy-based calcium fortified with 40ug Vit D flavoured and textured. All formulations to be supplied food grade and product tested by Dairygold Co-operative Society, Mitchelstown, Ireland. Participants: 60 Post-menopausal women with osteopenia as determined by site-specific bone mineral density BMD (DXA) diagnosed and screened by a clinician and for dietary intake of calcium and Vit D by a clinical dietitian.
Interventions
DIETARY_SUPPLEMENTMilk-based protein matrix (MBPM)
Ingestion of the Test Product at 10:00 pm, post-absorptive of the evening meal, each day for the 24 week period of intervention
DIETARY_SUPPLEMENTHabitual dietary behaviour
Subjects to maintain habitual dietary behaviour for the 24 week intervention
Sponsors
Dairygold Cooperative Society
University of Limerick
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A block randomised, controlled study among healthy, post-menopausal women with osteopenia receiving a milk-based protein supplement (MBPS) in the evening, or not (CONTROL), for a period of 24 weeks.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Post-menopausal women aged 50-70y. Assessed by site-specific BMD to be osteopenic. Assessed by clinical screen to be otherwise healthy and free from other illness or current medication likely to influence the study outcome.
Exclusion criteria
* Intolerance to dairy-based food products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerial Bone Mineral Density (BMD) | Change from Baseline BMD at 24 weeks | Site specific (hip and lumbar) BMD measured by Dual Energy X-ray Absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Resorption | Change from Baseline CTX, NTX and DPD at 24 weeks | Measured by biomarkers of bone resorption in fasting blood, i.e. C-terminal telopeptide of type I collagen (CTX, ng/ml), and diurnal (24h) urinary deoxypyridinoline (DPD, nmol/mmol creatinine) and N-terminal telopeptide of type I collagen (NTX, nmol/mmol creatinine) excretion normalised for urinary creatinine. |
| Bone Formation | Change from Baseline P1NP at 24 weeks | Measured by a biomarker of bone formation in fasting blood, i.e. serum pro-collagen type 1 N-terminal propeptide (P1NP, ng/ml) |
Countries
Ireland
Outcome results
None listed