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NCT Number: NCT01183299

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

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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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Aerospace Center

Cologne, North Rhine-Westphalia, 51147, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary salt intake

Other

Primary outcomes

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

    Time frame: after 14 days of high and low salt intake

Secondary outcomes

  1. To determine the effect of salt intake on acid base metabolism in bed rest

    Time frame: after 14 days of high and low salt intake

  2. To determine the effect of salt intake on electrolyte metabolism in bed rest

    Time frame: after 14 days of high and low salt intake

  3. To determine the effect of salt intake on the circulation system in bed rest

    Time frame: after 14 days of high and low salt intake

  4. To determine the effect of salt intake on energy metabolism in bed rest

    Time frame: after 14 days of high and low salt intake

Sponsors and collaborators

Lead sponsor

DLR German Aerospace Center

Other

Collaborators

  • Charite University, Berlin, Germany
  • University Hospital Tuebingen
  • University of Erlangen-Nürnberg

Registry information

Official study title

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

Acronym: SL7

Important dates

Study start
2005
Study completion
2006
First posted
Aug 17, 2010
Registry last updated
Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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