Milk Protein and Bone Health in Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bone and Bones, Osteoporosis, Postmenopausal, Osteoporosis Risk

Intervention / Treatment
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* Dietary Supplement: Milk-based protein matrix (MBPM)
* Dietary Supplement: Habitual dietary behaviour


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milk-based protein matrix (MBPM)<br>Intervention: Dietary Supplement : Test Product Intervention: Diagnostic Test : Aerial Bone Mineral Density (BMD) Intervention: Diagnostic Test : Bone Turnover Composition of Test Product - 25g of milk-based proteins + 1000mg dairy-based calcium fortified with 40ug Vit D flavoured and textured supplied food grade and product tested by Dairygold Co-operative Society, Mitchelstown, Ireland. | Dietary Supplement: Milk-based protein matrix (MBPM)<br>* Ingestion of the Test Product at 10:00 pm, post-absorptive of the evening meal, each day for the 24 week period of intervention<br>|
| Other: CONTROL<br>Intervention: Habitual dietary behaviour Intervention: Diagnostic Test : Aerial Bone Mineral Density (BMD) Intervention: Diagnostic Test : Bone Turnover | Dietary Supplement: Habitual dietary behaviour<br>* Subjects to maintain habitual dietary behaviour for the 24 week intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Postmenopausal, Bone Turnover Markers, Dairy Products