Salt Intake and Lactobacillus Abundance | NCT02971787

Studies
Salt Intake and Lactobacillus Abundance

NCT02971787

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 11, 2022Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Healthy Volunteers
Probiotics
Sodium

Interventions

Probiotics
Salt

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 2022

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

Nov 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 18, 2016

First Submission Date that Met QC Criteria

Nov 21, 2016

First Posted Date

Nov 23, 2016Estimated

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, 2022

Last Update Posted Date

Jul 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anja Maehler, Principle Investigator, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

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

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
Probiotics and salt	Experimental	Lactobacillus enrichment and salt increase	Dietary Supplement: Probiotics Dietary Supplement: Salt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Dietary Supplement	Day 1-21: 2 capsules per day	Probiotics and salt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease of relative abundance of four lactobacillus species		14 days

Secondary Outcomes

Measure	Description	Time Frame
Increase of systolic blood pressure		14 days
Increase of pulse wave velocity		14 days
Increase of lymphocytic pro-inflammatory mediators

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men
18 - 50 years
Body mass index 18,5 - 29,9 kg/m2

Exclusion Criteria:

Clinically relevant heart, lung, liver, and kidney disease
Current or chronic infections
Habitual intake of probiotics or dietary supplements

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anja Maehler, PhD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Experimental and Clinical Research Center		Berlin		13125	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33375942	Result	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.

ID	Term
D019936	Probiotics
D012492	Salts

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena