Bone MetabolismSL7NCT01183299
Salty Life 7 Study: Effect of High Salt Intake on Several Physiological Systems in Immobilisation
A study testing Dietary salt intake in people with Bone Metabolism and Electrolyte Metabolism, run by DLR German Aerospace Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Metabolism, Electrolyte Metabolism, Acid-Base Metabolism
- What is being tested?
- Dietary salt intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age: 20-35 years
- Weight: 65±85kg
- Height:180±10cm.
- Successfully completed medical \& psychological screening
Who cannot join
- 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
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- Risk for thrombosis
- Smoking
- Diabetes
- Rheumatism
- Bone Fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bone Metabolism, Electrolyte Metabolism, Acid-Base Metabolism, Energy Metabolism, Circulation System
- Being tested
- Dietary salt intake
- Keywords
- bone metabolism, salt intake, acid base balance, bed rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary salt intakeOther
| Study group | Role | What they receive |
|---|---|---|
| High salt intake | Active comparator | Not described Receives: Other: Dietary salt intake |
| Low salt intake | Placebo comparator | Not described Receives: Other: Dietary salt intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of salt intake on bone metabolism in bed rest
Measured: after 14 days of high and low salt intake
Secondary outcomes (4)
To determine the effect of salt intake on acid base metabolism in bed rest
Measured: after 14 days of high and low salt intake
To determine the effect of salt intake on electrolyte metabolism in bed rest
Measured: after 14 days of high and low salt intake
To determine the effect of salt intake on the circulation system in bed rest
Measured: after 14 days of high and low salt intake
To determine the effect of salt intake on energy metabolism in bed rest
Measured: after 14 days of high and low salt intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startApr 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg, University Hospital Tuebingen
- Investigators
- Francisca May, Dr, Principal investigator, German Aerospace Center (DLR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183299
- Sponsor's protocol ID
- DLR-2005049
- Acronym
- SL7
- Status last verified
- Jul 2011
- First submitted
- 17 Jun 2010
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a High Salt Intake on Sodium Retention, Bone Metabolism and Acid-base Balance in Immobilised Test Subjects
- ClinicalTrials.gov ID
- NCT01183299
- Acronym / sponsor ID
- SL7 / DLR-2005049
- Conditions
- Bone Metabolism, Electrolyte Metabolism, Acid-Base Metabolism, Energy Metabolism, Circulation System
- Keywords
- bone metabolism, salt intake, acid base balance, bed rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg, University Hospital Tuebingen
- Study start
- Apr 2005
- Study completion
- Apr 2006
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High salt intake | Active comparator | Other: Dietary salt intake |
| Low salt intake | Placebo comparator | Other: Dietary salt intake |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Age: 20-35 years
- Weight: 65±85kg
- Height:180±10cm.
- Successfully completed medical \& psychological screening
Key exclusion criteria (11 listed)
- Drugs- and alcohol abuse
- Hyperlipidemia
- Obesity
- Renal diseases
- Participant of another study in the same time frame and 3 months before starting the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary salt intake | Other | High salt intake, Low salt intake |
Primary outcome
To determine the effect of salt intake on bone metabolism in bed rest
Time frame: after 14 days of high and low salt intake
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- Derived from this study: PubMed 25112732Rucci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisca May, Dr principal investigator
German Aerospace Center (DLR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary salt intake in people with Bone Metabolism and Electrolyte Metabolism, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of salt intake on bone metabolism in bed rest (time frame: after 14 days of high and low salt intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01183299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.