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CompletedNCT01183299SL7Updated Jul 8, 2011

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

An interventional study of Dietary salt intake in Bone Metabolism, Electrolyte Metabolism and Acid-Base Metabolism, sponsored by DLR German Aerospace Center. Completed at 1 site in Germany. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-08.

Sponsored by DLR German Aerospace Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

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

Keywords

  • bone metabolism
  • salt intake
  • acid base balance
  • bed rest
03

In context

Lead sponsor

DLR German Aerospace Center is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    High salt intake

    Other: Dietary salt intake

  • Placebo comparator
    Low salt intake

    Other: Dietary salt intake

Interventions

  • OtherDietary salt intake
06

What researchers measure

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

07

Study locations

1 site
  • German Aerospace Center
    Cologne, NRW 51147, Germany
08

References and documents

Publications

  • 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. PubMed 25112732 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01183299
Lead sponsor
DLR German Aerospace Center
Collaborators
Charite University, Berlin, Germany, University of Erlangen-Nürnberg, University Hospital Tuebingen
First posted
Aug 17, 2010
Start date
Apr 2005
Completion
Apr 2006
Last update
Jul 8, 2011

Study contacts

Francisca May, Dr
principal investigator · German Aerospace Center (DLR)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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