Skip to main content
OpenTrials
Completed

NCT Number: NCT03701113

Milk Protein and Bone Health in Postmenopausal Women

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..

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone And Bones Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis Risk Osteoporosis, Postmenopausal

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, V94 T9PX, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Dairygold Cooperative Society

Registry information

Official study 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

Acronym: OSTEOMILK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.