Salt Intake and Lactobacillus Abundance

July 7, 2022 updated by: Anja Maehler, Charite University, Berlin, Germany

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Experimental and Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics and salt
Lactobacillus enrichment and salt increase
Dietary supplement: Probiotics
Day 1-21: 2 capsules per day
Other Names:
  • Vivomixx
Dietary supplement: Salt
Day 8-21: 10 tablets à 600 mg per day
Other Names:
  • Slow Sodium Tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Anja Maehler, PhD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Tissue Salt 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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