Osteoporosis, Postmenopausal Clinical Trial
— OSTEOMILKOfficial title:
Evaluation of a Milk-Based Protein Supplement to Effect a Positive Change in Bone Health in Post-Menopausal Women Aged 50 to 70 y at Risk of Osteoporosis
Verified date | April 2021 |
Source | University of Limerick |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 64 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | University of Limerick | Limerick |
Lead Sponsor | Collaborator |
---|---|
University of Limerick | Dairygold Cooperative Society |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aerial Bone Mineral Density (BMD) | Site specific (hip and lumbar) BMD measured by Dual Energy X-ray Absorptiometry (DXA) | Change from Baseline BMD at 24 weeks | |
Secondary | Bone Resorption | 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. | Change from Baseline CTX, NTX and DPD at 24 weeks | |
Secondary | Bone Formation | Measured by a biomarker of bone formation in fasting blood, i.e. serum pro-collagen type 1 N-terminal propeptide (P1NP, ng/ml) | Change from Baseline P1NP at 24 weeks |
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