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OpenTrials
Completed

NCT Number: NCT02971787

Salt Intake and Lactobacillus Abundance

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

Completed

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Key information

Conditions

Healthy Volunteers Probiotics Sodium

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Experimental and Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

Day 1-21: 2 capsules per day

Other names: Vivomixx

Salt

Dietary Supplement

Day 8-21: 10 tablets à 600 mg per day

Other names: Slow Sodium Tablets

Primary outcomes

  1. Decrease of relative abundance of four lactobacillus species

    Time frame: 14 days

Secondary outcomes

  1. Increase of systolic blood pressure

    Time frame: 14 days

  2. Increase of pulse wave velocity

    Time frame: 14 days

  3. Increase of lymphocytic pro-inflammatory mediators

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2016
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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