HealthyBSALTNCT02509962
Increased Salt Intake in Healthy Men
A study testing Slow sodium tablets in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Slow sodium tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Jul 2017
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 18.5 - 29.9 kg/m2
Who cannot join
- clinically relevant heart, lung, liver, and kidney diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Increased Salt Intake on Metabolic, Cardiovascular and Immunoregulatory Functions in Healthy Men
To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men.
- Conditions
- Healthy
- Being tested
- Slow sodium tablets
- Keywords
- Energy metabolism, Glucose tolerance, Blood pressure, Immunoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow sodium tabletsDietary supplement
6 g sodium chloride per day over 14 days
| Study group | Role | What they receive |
|---|---|---|
| Slow sodium tablets | Experimental | Increased dietary salt intake Receives: Dietary Supplement: Slow sodium tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber)
Measured: Change to baseline at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Maehler, Charite University, Berlin, Germany
- Investigators
- Michael Boschmann, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509962
- Sponsor's protocol ID
- Tissue Salt 3
- Acronym
- BSALT
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2015
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilck N, Matus MG, Kearney SM, Olesen SW, Forslund K, Bartolomaeus H, Haase S, Mahler A, Balogh A, Marko L, Vvedenskaya O, Kleiner FH, Tsvetkov D, Klug L, Costea PI, Sunagawa S, Maier L, Rakova N, Schatz V, Neubert P, Fratzer C, Krannich A, Gollasch M, Grohme DA, Corte-Real BF, Gerlach RG, Basic M, Typas A, Wu C, Titze JM, Jantsch J, Boschmann M, Dechend R, Kleinewietfeld M, Kempa S, Bork P, Linker RA, Alm EJ, Muller DN. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017 Nov 30;551(7682):585-589. doi: 10.1038/nature24628. Epub 2017 Nov 15.
PubMed 29143823Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28.
PubMed 33906377
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Increased Salt Intake on Metabolic, Cardiovascular and Immunoregulatory Functions in Healthy Men
- ClinicalTrials.gov ID
- NCT02509962
- Acronym / sponsor ID
- BSALT / Tissue Salt 3
- Conditions
- Healthy
- Keywords
- Energy metabolism, Glucose tolerance, Blood pressure, Immunoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Jul 2015 (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.
To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow sodium tablets | Experimental | Dietary Supplement: Slow sodium tabletsIncreased dietary salt intake |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index 18.5 - 29.9 kg/m2
Key exclusion criteria (1 listed)
- clinically relevant heart, lung, liver, and kidney diseases
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 |
|---|---|---|
| Slow sodium tablets6 g sodium chloride per day over 14 days | Dietary supplement | Slow sodium tablets |
Primary outcome
Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber)
Time frame: Change to baseline at day 14
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 11 Jul 2022.
- Results publication: PubMed 29143823Wilck N, Matus MG, Kearney SM, Olesen SW, Forslund K, Bartolomaeus H, Haase S, Mahler A, Balogh A, Marko L, Vvedenskaya O, Kleiner FH, Tsvetkov D, Klug L, Costea PI, Sunagawa S, Maier L, Rakova N, Schatz V, Neubert P, Fratzer C, Krannich A, Gollasch M, Grohme DA, Corte-Real BF, Gerlach RG, Basic M, Typas A, Wu C, Titze JM, Jantsch J, Boschmann M, Dechend R, Kleinewietfeld M, Kempa S, Bork P, Linker RA, Alm EJ, Muller DN. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017 Nov 30;551(7682):585-589. doi: 10.1038/nature24628. Epub 2017 Nov 15.
- Derived from this study: PubMed 33906377Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28.
- Results publicationLink provided by the sponsor.
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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.
Michael Boschmann, Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow sodium tablets in people with Healthy, run by Charite University, Berlin, Germany 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 1 inclusion and 1 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 11 Jul 2022. 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. 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?
Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber) (time frame: Change to baseline at day 14). 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 NCT02509962, which also lists 2 linked publications.
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 11 Jul 2022.