Healthy VolunteersNCT02971787
Salt Intake and Lactobacillus Abundance
A study testing Probiotics and Salt in people with Healthy Volunteers and Probiotics, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Probiotics, Sodium
- What is being tested?
- Probiotics and Salt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Jun 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- 18 - 50 years
- Body mass index 18,5 - 29,9 kg/m2
Who cannot join
- Clinically relevant heart, lung, liver, and kidney disease
- Current or chronic infections
- Habitual intake of probiotics or dietary supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men
To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men
- Conditions
- Healthy Volunteers, Probiotics, Sodium
- Being tested
- Probiotics, Salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Vivomixx
Day 1-21: 2 capsules per day
SaltDietary supplement
Also called Slow Sodium Tablets
Day 8-21: 10 tablets à 600 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and salt | Experimental | Lactobacillus enrichment and salt increase Receives: Dietary Supplement: Probiotics; Dietary Supplement: Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of relative abundance of four lactobacillus species
Measured: 14 days
Secondary outcomes (3)
Increase of systolic blood pressure
Measured: 14 days
Increase of pulse wave velocity
Measured: 14 days
Increase of lymphocytic pro-inflammatory mediators
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 posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
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 Healthy VolunteersStudies 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
- 8 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
- Anja Maehler, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971787
- Sponsor's protocol ID
- Tissue Salt 5
- Status last verified
- Jul 2022
- First submitted
- 18 Nov 2016
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.
PubMed 33375942
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
- Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men
- ClinicalTrials.gov ID
- NCT02971787
- Acronym / sponsor ID
- Tissue Salt 5
- Conditions
- Healthy Volunteers, Probiotics, Sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Nov 2016 (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 investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species 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 |
|---|---|---|
| Probiotics and salt | Experimental | Dietary Supplement: Probiotics, Dietary Supplement: SaltLactobacillus enrichment and salt increase |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- 18 - 50 years
- Body mass index 18,5 - 29,9 kg/m2
Key exclusion criteria (3 listed)
- Clinically relevant heart, lung, liver, and kidney disease
- Current or chronic infections
- Habitual intake of probiotics or dietary supplements
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 |
|---|---|---|
| ProbioticsAlso: VivomixxDay 1-21: 2 capsules per day | Dietary supplement | Probiotics and salt |
| SaltAlso: Slow Sodium TabletsDay 8-21: 10 tablets à 600 mg per day | Dietary supplement | Probiotics and salt |
Primary outcome
Decrease of relative abundance of four lactobacillus species
Time frame: 14 days
3 secondary outcomes
Increase of systolic blood pressure
Time frame: 14 days
Increase of pulse wave velocity
Time frame: 14 days
Increase of lymphocytic pro-inflammatory mediators
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 33375942Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.
- Follow-up studyLink provided by the sponsor.
- 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.
Anja Maehler, PhD 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 Probiotics and Salt in people with Healthy Volunteers and Probiotics, 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 3 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?
Decrease of relative abundance of four lactobacillus species (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 NCT02971787, 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.