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临床试验/NCT01713634
NCT01713634已完成不适用

Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism During Spaceflight and Recovery

National Aeronautics and Space Administration (NASA)2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Change in urinary n-telopeptide after 120 days of space flight compared to preflight

研究概览

简要总结

Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a condition that affects millions of men and women on Earth each year. Many countermeasures to bone loss have been proposed, and many have been evaluated to some degree. To date, those showing potential have focused on either exercise or pharmacological interventions, but none have targeted dietary intake alone as a factor to predict or minimize bone loss during spaceflight. The investigators proposed to document how the ratio of acid precursors to base precursors in the diet is related to directional changes in markers of bone resorption and formation during flight and recovery from flight. There is a high likelihood for success in predicting the extent of bone loss from dietary intake patterns of astronauts during spaceflight, given that this concept is strongly anchored in data obtained from ground-based experiments in our laboratory and others. The notion of manipulating diet to minimize bone loss could also have significant social and economic impacts for NASA and for the general public - especially given the increasing trends for diets that are high in animal protein and low in fruits and vegetables. The results of the proposed experiments will lead to development of a dietary countermeasure for bone loss consisting of a balanced diet with no associated risks for side effects that might be present with pharmaceuticals or supplements, no requirement for payload mass, and no additional crew time necessary during flight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Astronauts flying on long-duration (3-6 months) spaceflights

排除标准

  • Non-astronauts

结局指标

主要结局

Change in urinary n-telopeptide after 120 days of space flight compared to preflight

时间窗: 120 days

Change in urinary n-telopeptide after 180 days of space flight compared to preflight

时间窗: 180 days

Change in urinary calcium after 180 days of space flight compared to preflight

时间窗: 180 days

Change in urinary n-telopeptide after 15 days of space flight compared to preflight

时间窗: 15 days

24-h NTX will be used as an indicator of bone resorption

Change in urinary n-telopeptide after 30 days of space flight compared to preflight

时间窗: 30 days

Change in urinary calcium after 60 days of space flight compared to preflight

时间窗: 60 days

Change in urinary calcium after 120 days of space flight compared to preflight

时间窗: 120 days

Change in urinary calcium after 15 days of space flight compared to preflight

时间窗: 15 days

Change in urinary n-telopeptide after 60 days of space flight compared to preflight

时间窗: 60 days

次要结局

  • Change in urinary calcium after 30 days of space flight compared to preflight(30 days)

研究者

发起方
National Aeronautics and Space Administration (NASA)
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Scott M. Smith

Manager for Nutritional Biochemistry

National Aeronautics and Space Administration (NASA)

研究点 (2)

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