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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03701113
Other study ID # 2018_04_05_EHS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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