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Milk Protein and Bone Health in Postmenopausal Women (OSTEOMILK)

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ClinicalTrials.gov Identifier: NCT03701113
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Dairygold Cooperative Society
Information provided by (Responsible Party):
University of Limerick

Brief Summary:
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..

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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

CONTROL
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Philip M Jakeman, PhD +35361202800 ext 2800 phil.jakeman@ul.ie
Contact: Mary Clarke-Moloney, BSc +35361204230 ext 4230 mary.clarke-moloney@ul.ie

Locations
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Ireland
University of Limerick Recruiting
Limerick, Ireland, V94 T9PX
Contact: Philip M Jakeman, PhD    +35361202800 ext 2800    phil.jakeman@ul.ie   
Contact: Catherine Norton, PhD    +35361204780    catherine.norton@ul.ie   
Principal Investigator: Philip M Jakeman, PhD         
Sub-Investigator: Catherine Norton, PhD         
Sponsors and Collaborators
University of Limerick
Dairygold Cooperative Society
Investigators
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Principal Investigator: Philip M Jakeman, PhD University of Limerick
  Study Documents (Full-Text)

Documents provided by University of Limerick:
Statistical Analysis Plan  [PDF] August 13, 2018


Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 2018_04_05_EHS
Contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick, Ireland

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Responsible Party: University of Limerick
ClinicalTrials.gov Identifier: NCT03701113     History of Changes
Other Study ID Numbers: 2018_04_05_EHS
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Limerick:
Osteoporosis
Postmenopausal
Bone Turnover Markers
Dairy Products
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases