Milk Protein and Bone Health in Postmenopausal Women

NCT03701113 | Completed DMC

• 1 other identifier: 2018_04_05_EHS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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..

Conditions

Bone and Bones; Osteoporosis Risk; Osteoporosis, Postmenopausal

Keywords

Osteoporosis; Postmenopausal; Bone Turnover Markers; Dairy Products

Outcome Measures

Primary Outcomes (1)

• Aerial Bone Mineral Density (BMD)

  Site specific (hip and lumbar) BMD measured by Dual Energy X-ray Absorptiometry (DXA)

  Change from Baseline BMD at 24 weeks

Secondary Outcomes (2)

• Bone Resorption

  Change from Baseline CTX, NTX and DPD at 24 weeks

• Bone Formation

  Change from Baseline P1NP at 24 weeks

Study Arms (2)

Milk-based protein matrix (MBPM)

ACTIVE COMPARATOR

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)

CONTROL

OTHER

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

Dietary Supplement: Habitual dietary behaviour

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

Milk-based protein matrix (MBPM)

Habitual dietary behaviour DIETARY_SUPPLEMENT

Subjects to maintain habitual dietary behaviour for the 24 week intervention

CONTROL

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intolerance to dairy-based food products

Sponsors & Collaborators

• University of Limerick: lead
• Dairygold Cooperative Society: collaborator

Study Sites (1)

University of Limerick

Limerick, V94 T9PX, Ireland

Location

Related Links

• Center for Interventions in Inflammation Infection and Immunity

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Philip M Jakeman, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 9, 2018
• Study Start: October 22, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)