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临床试验/NCT01183299
NCT01183299已完成不适用

Influence of a High Salt Intake on Sodium Retention, Bone Metabolism and Acid-base Balance in Immobilised Test Subjects

DLR German Aerospace Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
To determine the effect of salt intake on bone metabolism in bed rest

研究概览

简要总结

The Salty Life 7 study aimed to examine the effect of a high salt (sodium chloride, NaCl) intake on different forms of sodium retention, acid-base balance and bone metabolism and other influenced physiological systems. Because of the fact that astronauts are a vulnerable group in this context, they were of special interest. Astronauts have a high salt intake, probably because of a reduced sense of taste, as well as an increased bone resorption resulting from the lowered mechanical load in space. In which forms sodium could be retained even without fluid retention (osmotically inactive)- contrary to the argumentation of physiological text books - and if the acid-base balance is connected to sodium chloride induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male test subjects. The study consisting of 2 x 21 days is carried out at the German Aerospace Center (DLR). After an adaptation period of 4 days, test subjects are immobilised in 6° head-down tilt bed rest (simulation model for some physiological changes in space) for 14 days during which they received a high (7.7 mmol NaCl/kgBW/d) and a low salt (0.7 mmol NaCl/kgBW/d) intake in cross-over design. The form of sodium retention is investigated by the calculation of daily metabolic sodium-, water- and potassium balances and by changes in body weight. The measurements of bone formation (bAP, PINP, Osteocalcin) markers as well as bone resorption markers (CTX, NTX) supply insight into the influences of a high salt intake on bone metabolism. Blood gas analysis and ph values of 24-h urine are used to gather information about accompanying changes in the acid-base balance. Further physiological systems like energy metabolism and circulation system are also under investigation.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 20-35 years
  • Weight: 65±85kg
  • Height:180±10cm.
  • Successfully completed medical & psychological screening

排除标准

  • Drugs- and alcohol abuse
  • Hyperlipidemia
  • Renal diseases
  • Participant of another study in the same time frame and 3 months before starting the study
  • Blood donation within the last three months before starting the study
  • Risk for thrombosis
  • Rheumatism
  • Bone Fracture

结局指标

主要结局

To determine the effect of salt intake on bone metabolism in bed rest

时间窗: after 14 days of high and low salt intake

次要结局

  • To determine the effect of salt intake on acid base metabolism in bed rest(after 14 days of high and low salt intake)
  • To determine the effect of salt intake on electrolyte metabolism in bed rest(after 14 days of high and low salt intake)
  • To determine the effect of salt intake on the circulation system in bed rest(after 14 days of high and low salt intake)
  • To determine the effect of salt intake on energy metabolism in bed rest(after 14 days of high and low salt intake)

研究者

申办方类型
Other

研究点 (2)

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