Salty Life 7 Study: Effect of High Salt Intake on Several Physiological Systems in Immobilisation

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Metabolism Electrolyte Metabolism Acid-Base Metabolism Energy Metabolism Circulation System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High salt intake

Group Type ACTIVE_COMPARATOR

Dietary salt intake

Intervention Type OTHER

Low salt intake

Group Type PLACEBO_COMPARATOR

Dietary salt intake

Intervention Type OTHER

Interventions

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Dietary salt intake

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Drugs- and alcohol abuse
* Hyperlipidemia
* Obesity
* 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
* Smoking
* Diabetes
* Rheumatism
* Bone Fracture

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes