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OpenTrials
Completed

NCT Number: NCT03024567

Randomized Study on Salt Intake and Energy Metabolism

To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

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 and women
  • 18 - 50 years
  • Body mass index 18.5 - 29.9 kg/m2

Exclusion criteria

  • Clinically relevant heart, lung, liver, and kidney diseases
  • Current or chronic infection
  • Habitual use of probiotics or dietary supplements
  • Pregnancy, lactation

Treatment and study plan

Salt

Dietary Supplement

10 capsules daily for 14 days

Placebo

Dietary Supplement

10 capsules daily for 14 days

Primary outcomes

  1. Dietary induced thermogenis (%)

    Time frame: 14 days

    Decrease of dietary induced thermogenis after salt vs. placebo

Secondary outcomes

  1. Systolic blood pressure (mmHg)

    Time frame: 14 days

    Increase of systolic blood pressure after salt vs. placebo

  2. Lymphocytic pro-inflammatory mediators

    Time frame: 14 days

    Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo

  3. Gut microbiome

    Time frame: 14 days

    Change of gut microbiome composition after salt vs. placebo

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study

Acronym: TS4

Important dates

Study start
2017
Primary completion
2017
Study completion
2021
First posted
Jan 19, 2017
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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