NCT02971787

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

November 18, 2016

Last Update Submit

July 7, 2022

Conditions

Healthy VolunteersProbioticsSodium

Outcome Measures

Primary Outcomes (1)

  • Decrease of relative abundance of four lactobacillus species

    14 days

Secondary Outcomes (3)

  • Increase of systolic blood pressure

    14 days

  • Increase of pulse wave velocity

    14 days

  • Increase of lymphocytic pro-inflammatory mediators

    14 days

Study Arms (1)

Probiotics and salt

EXPERIMENTAL

Lactobacillus enrichment and salt increase

Dietary Supplement: ProbioticsDietary Supplement: Salt

Interventions

ProbioticsDIETARY_SUPPLEMENT

Day 1-21: 2 capsules per day

Also known as: Vivomixx
Probiotics and salt
SaltDIETARY_SUPPLEMENT

Day 8-21: 10 tablets à 600 mg per day

Also known as: Slow Sodium Tablets
Probiotics and salt

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33375942RESULT

Related Links

MeSH Terms

Interventions

ProbioticsSalts

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesInorganic Chemicals

Study Officials

  • Anja Maehler, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)