Milk Protein and Bone Health in Postmenopausal Women (OSTEOMILK)

University of Limerick

Status: Completed

Conditions: Bone and Bones; Osteoporosis Risk; Osteoporosis, Postmenopausal

Treatments: Dietary Supplement: Milk-based protein matrix (MBPM); Dietary Supplement: Habitual dietary behaviour

Study type: Interventional

Funder types: Other

Identifiers

NCT03701113

2018_04_05_EHS

Details and patient eligibility

About

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..

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Milk-based protein matrix (MBPM)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Milk-based protein matrix (MBPM)

CONTROL

Other group

Description:

Intervention: Habitual dietary behaviour Intervention: Diagnostic Test : Aerial Bone Mineral Density (BMD) Intervention: Diagnostic Test : Bone Turnover

Treatment:

Dietary Supplement: Habitual dietary behaviour