Milk Protein and Bone Health in Postmenopausal Women

What this trial studies

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.

Conditions in scope

• Bone and Bones
• Osteoporosis Risk
• Osteoporosis, Postmenopausal

Interventions

• 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
• Habitual dietary behaviour (Dietary Supplement) — Subjects to maintain habitual dietary behaviour for the 24 week intervention

Who can join

Women only · Ages 50 Years to 70 Years · 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2018-10-22
• Primary completion: 2019-07-30
• Last update posted: 2025-01-29
• First posted: 2018-10-09

Sponsor & contact

Lead sponsor: University of Limerick (Other)

Collaborators: Dairygold Cooperative Society

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Aerial Bone Mineral Density (BMD) (Change from Baseline BMD at 24 weeks)
  Site specific (hip and lumbar) BMD measured by Dual Energy X-ray Absorptiometry (DXA)

Related ClearedRx care

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