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Salty Life 7 Study: Effect of High Salt Intake on Several Physiological Systems in Immobilisation (SL7)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183299
First Posted: August 17, 2010
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Charite University, Berlin, Germany
University of Erlangen-Nürnberg
University Hospital Tuebingen
Information provided by:
DLR German Aerospace Center
June 17, 2010
August 17, 2010
July 8, 2011
April 2005
Not Provided
To determine the effect of salt intake on bone metabolism in bed rest [ Time Frame: after 14 days of high and low salt intake ]
Same as current
Complete list of historical versions of study NCT01183299 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the effect of salt intake on electrolyte metabolism in bed rest [ Time Frame: after 14 days of high and low salt intake ]
  • 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 ]
  • To determine the effect of salt intake on energy metabolism in bed rest [ Time Frame: after 14 days of high and low salt intake ]
Same as current
Not Provided
Not Provided
 
Salty Life 7 Study: Effect of High Salt Intake on Several Physiological Systems in Immobilisation
Influence of a High Salt Intake on Sodium Retention, Bone Metabolism and Acid-base Balance in Immobilised Test Subjects
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Bone Metabolism
  • Electrolyte Metabolism
  • Acid-Base Metabolism
  • Energy Metabolism
  • Circulation System
Other: Dietary salt intake
  • Active Comparator: High salt intake
    Intervention: Other: Dietary salt intake
  • Placebo Comparator: Low salt intake
    Intervention: Other: Dietary salt intake
Rucci N, Capulli M, Piperni SG, Cappariello A, Lau P, Frings-Meuthen P, Heer M, Teti A. Lipocalin 2: a new mechanoresponding gene regulating bone homeostasis. J Bone Miner Res. 2015 Feb;30(2):357-68. doi: 10.1002/jbmr.2341.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
April 2006
Not Provided

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
Sexes Eligible for Study: Male
20 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01183299
DLR-2005049
No
Not Provided
Not Provided
Not Provided
DLR German Aerospace Center
  • Charite University, Berlin, Germany
  • University of Erlangen-Nürnberg
  • University Hospital Tuebingen
Principal Investigator: Francisca May, Dr German Aerospace Center (DLR)
DLR German Aerospace Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP