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| Name | Class |
|---|---|
| Dairygold Cooperative Society | UNKNOWN |
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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk-based protein matrix (MBPM) | Active Comparator | 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. |
|
| CONTROL | Other | Intervention: Habitual dietary behaviour Intervention: Diagnostic Test : Aerial Bone Mineral Density (BMD) Intervention: Diagnostic Test : Bone Turnover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk-based protein matrix (MBPM) | Dietary Supplement | Ingestion of the Test Product at 10:00 pm, post-absorptive of the evening meal, each day for the 24 week period of intervention |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip M Jakeman, PhD | University of Limerick | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Limerick | Limerick | V94 T9PX | Ireland |
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| Label | URL |
|---|---|
| Center for Interventions in Inflammation Infection and Immunity | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 2018_04_05_EHS | Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 13, 2018 | Sep 24, 2018 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2018 | Sep 24, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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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.
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| Habitual dietary behaviour | Dietary Supplement | Subjects to maintain habitual dietary behaviour for the 24 week intervention |
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| 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 |
Contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick, Ireland |
| D009750 |
| Nutritional and Metabolic Diseases |