Milk Protein and Bone Health in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-07-30

Brief Summary

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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..

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Detailed Description

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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.

Conditions

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Bone and Bones Osteoporosis Risk Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Milk-based protein matrix (MBPM)

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.

Group Type ACTIVE_COMPARATOR

Milk-based protein matrix (MBPM)

Intervention Type 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

CONTROL

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

Group Type OTHER

Habitual dietary behaviour

Intervention Type DIETARY_SUPPLEMENT

Subjects to maintain habitual dietary behaviour for the 24 week intervention

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Habitual dietary behaviour

Subjects to maintain habitual dietary behaviour for the 24 week intervention

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip M Jakeman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

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University of Limerick

Limerick, , Ireland

Site Status

Countries

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Ireland

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Study Protocol

Contact The EHS Research Ethics Contact Point of the Education and Health Sciences Research Ethics Committee, Room E1003, University of Limerick, Limerick, Ireland

View Document