Osteoporosis, Postmenopausal Clinical Trial
— MBPSOfficial title:
Evaluation of a Milk-Based Nutritional Supplement to Modify Diurnal Rates of Bone Turnover and Effect a Positive Change in Bone Health in Post-Menopausal Women at Risk of Osteoporosis
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 lifecycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause).The research to be undertaken investigates the pluripotent effect of dairy-based products on the regulation of the diurnal process of bone metabolism in post-menopausal women at risk of osteoporosis.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | April 4, 2019 |
Est. primary completion date | December 28, 2018 |
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 | Co Limerick |
Lead Sponsor | Collaborator |
---|---|
University of Limerick | Dairygold Cooperative Society Ltd |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone turnover | A balance of the difference between the magnitude and time course of the acute change (0-4h) in serum C-terminal telopeptide of type 1 collagen (CTX) in ng/mL, a measure of bone resorption, and procollagen type 1 amino-terminal propeptide (P1NP) in ng/ml, a measure of bone formation and diurnal change in bone resorption measured by 24h urinary excretion of deoxypyridinoline (Dpd), a marker of bone resorption, normalised to creatinine. Units nmolDPD/mmolCr | Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine) | |
Secondary | Change in regulator of bone metabolism - PTH | The magnitude and time course of the acute change (0-4h) in serum parathyroid hormone (PTH) measured in pmol/L | Pre-ingestion,1,2,3 and 4hours post-ingestion | |
Secondary | Change in regulator of bone metabolism - RANKL | The magnitude and time course of the acute change (0-4h) in serum receptor activator of the nuclear factor ?B ligand (RANKL) measured in ng/dL | Pre-ingestion,1,2,3 and 4hours post-ingestion | |
Secondary | Change in regulator of bone metabolism - OPG | The magnitude and time course of the acute change (0-4h) in serum receptor activator of the osteoprotegerin (OPG) measured in pg/mL | Pre-ingestion,1,2,3 and 4hours post-ingestion | |
Secondary | Incretin peptide (GIP) | The magnitude and time course of the acute change (0-4h) in enterogastric peptide glucose-dependent insulinotropic peptide (GIP1-42) measured in pg/mL | Pre-ingestion,1,2,3 and 4hours post-ingestion | |
Secondary | Incretin peptide (GLP-1) | The magnitude and time course of the acute change (0-4h) in enterogastric glucagon-like peptide-1 (GLP-17-36) measured in pg/mL | Pre-ingestion,1,2,3 and 4hours post-ingestion |
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