HealthyTS4NCT03024567
Randomized Study on Salt Intake and Energy Metabolism
A study testing Salt in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Jul 2021
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18 - 50 years
- Body mass index 18.5 - 29.9 kg/m2
Who cannot join
- Clinically relevant heart, lung, liver, and kidney diseases
- Current or chronic infection
- Habitual use of probiotics or dietary supplements
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study
To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota
- Conditions
- Healthy
- Being tested
- Salt, Placebo
- Keywords
- Calorimetry, Blood pressure, Immunophenotyping, Gut microbial composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaltDietary supplement
10 capsules daily for 14 days
PlaceboDietary supplement
10 capsules daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Salt | Active comparator | 6 grams sodium chloride per day for 14 days Receives: Dietary Supplement: Salt |
| Placebo | Placebo comparator | 6 grams gelatine per day for 14 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary induced thermogenis (%)
Decrease of dietary induced thermogenis after salt vs. placebo
Measured: 14 days
Secondary outcomes (3)
Systolic blood pressure (mmHg)
Increase of systolic blood pressure after salt vs. placebo
Measured: 14 days
Lymphocytic pro-inflammatory mediators
Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo
Measured: 14 days
Gut microbiome
Change of gut microbiome composition after salt vs. placebo
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionJul 2021
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024567
- Sponsor's protocol ID
- Tissue Salt 4
- Acronym
- TS4
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253.
PubMed 35057434
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 Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03024567
- Acronym / sponsor ID
- TS4 / Tissue Salt 4
- Conditions
- Healthy
- Keywords
- Calorimetry, Blood pressure, Immunophenotyping, Gut microbial composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 19 Jan 2017 (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 perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt | Active comparator | Dietary Supplement: Salt6 grams sodium chloride per day for 14 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo6 grams gelatine per day for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- 18 - 50 years
- Body mass index 18.5 - 29.9 kg/m2
Key exclusion criteria (4 listed)
- Clinically relevant heart, lung, liver, and kidney diseases
- Current or chronic infection
- Habitual use of probiotics or dietary supplements
- Pregnancy, lactation
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 |
|---|---|---|
| Salt10 capsules daily for 14 days | Dietary supplement | Salt |
| Placebo10 capsules daily for 14 days | Dietary supplement | Placebo |
Primary outcome
Dietary induced thermogenis (%)
Time frame: 14 days
Decrease of dietary induced thermogenis after salt vs. placebo
3 secondary outcomes
Systolic blood pressure (mmHg)
Time frame: 14 days
Lymphocytic pro-inflammatory mediators
Time frame: 14 days
Gut microbiome
Time frame: 14 days
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 35057434Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt 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 3 inclusion and 4 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. 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?
Dietary induced thermogenis (%) (time frame: 14 days). 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 NCT03024567, 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 11 Jul 2022.