Milk Protein and Bone Health in Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

— OSTEOMILK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701113
• Other study ID #: 2018_04_05_EHS
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: April 2021
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone and Bones
• Osteoporosis
• Osteoporosis Risk
• Osteoporosis, Postmenopausal

Intervention

Dietary Supplement:
• Milk-based protein matrix (MBPM)
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
Subjects to maintain habitual dietary behaviour for the 24 week intervention

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick

Sponsors (2)

Lead Sponsor	Collaborator
University of Limerick	Dairygold Cooperative Society

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bone Resorption	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.	Change from Baseline CTX, NTX and DPD at 24 weeks
Secondary	Bone Formation	Measured by a biomarker of bone formation in fasting blood, i.e. serum pro-collagen type 1 N-terminal propeptide (P1NP, ng/ml)	Change from Baseline P1NP at 24 weeks

External Links

•   Center for Interventions in Inflammation Infection and Immunity