Milk Protein and Bone Health in Postmenopausal Women (OSTEOMILK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03701113|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone and Bones Osteoporosis Risk Osteoporosis, Postmenopausal||Dietary Supplement: Milk-based protein matrix (MBPM) Dietary Supplement: Habitual dietary behaviour||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official 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|
|Estimated Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Milk-based protein matrix (MBPM)
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)
Ingestion of the Test Product at 10:00 pm, post-absorptive of the evening meal, each day for the 24 week period of intervention
Intervention: Habitual dietary behaviour Intervention: Diagnostic Test : Aerial Bone Mineral Density (BMD) Intervention: Diagnostic Test : Bone Turnover
Dietary Supplement: Habitual dietary behaviour
Subjects to maintain habitual dietary behaviour for the 24 week intervention
- Aerial Bone Mineral Density (BMD) [ Time Frame: Change from Baseline BMD at 24 weeks ]Site specific (hip and lumbar) BMD measured by Dual Energy X-ray Absorptiometry (DXA)
- Bone Resorption [ Time Frame: 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 [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701113
|Contact: Philip M Jakeman, PhD||+35361202800 ext email@example.com|
|Contact: Mary Clarke-Moloney, BSc||+35361204230 ext firstname.lastname@example.org|
|University of Limerick||Recruiting|
|Limerick, Ireland, V94 T9PX|
|Contact: Philip M Jakeman, PhD +35361202800 ext 2800 email@example.com|
|Contact: Catherine Norton, PhD +35361204780 firstname.lastname@example.org|
|Principal Investigator: Philip M Jakeman, PhD|
|Sub-Investigator: Catherine Norton, PhD|
|Principal Investigator:||Philip M Jakeman, PhD||University of Limerick|