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临床试验/NCT03701113
NCT03701113已完成不适用

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

University of Limerick2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Aerial Bone Mineral Density (BMD)

研究概览

简要总结

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..

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Intolerance to dairy-based food products

结局指标

主要结局

Aerial Bone Mineral Density (BMD)

时间窗: Change from Baseline BMD at 24 weeks

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

次要结局

  • Bone Resorption(Change from Baseline CTX, NTX and DPD at 24 weeks)
  • Bone Formation(Change from Baseline P1NP at 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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