Clinical trial NCT03701113: Milk Protein and Bone Health in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone and Bones
Osteoporosis Risk
Osteoporosis, Postmenopausal
Keywords: Osteoporosis
Postmenopausal
Bone Turnover Markers
Dairy Products
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Dairygold Cooperative Society
First posted: 2018-10-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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..

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.

Eligibility 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

Primary outcomes:
measure: Aerial Bone Mineral Density (BMD)
timeFrame: Change from Baseline BMD at 24 weeks
Secondary outcomes:
measure: Bone Resorption
timeFrame: Change from Baseline CTX, NTX and DPD at 24 weeks
measure: Bone Formation
timeFrame: Change from Baseline P1NP at 24 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Philip M Jakeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: