Salty Life 7 Study: Effect of High Salt Intake on Several... | NCT01183299

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

NCT01183299

Sponsor

DLR German Aerospace Center

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

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

Interventions

Dietary salt intake

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Aug 13, 2010

First Posted Date

Aug 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

DLR German Aerospace CenterOTHER

Collaborators

Name	Class
Charite University, Berlin, Germany	OTHER
University of Erlangen-Nürnberg	OTHER
University Hospital Tuebingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High salt intake	Active Comparator		Other: Dietary salt intake
Low salt intake	Placebo Comparator		Other: Dietary salt intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary salt intake	Other		High salt intake Low salt intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the effect of salt intake on bone metabolism in bed rest		after 14 days of high and low salt intake

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisca May, Dr	German Aerospace Center (DLR)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
German Aerospace Center		Cologne	North Rhine-Westphalia	51147	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25112732	Derived	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.