Randomized Study on Salt Intake and Energy Metabolism (TS4)

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

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Salt
6 grams sodium chloride per day for 14 days
Dietary supplement: Salt
10 capsules daily for 14 days
Placebo Comparator: Placebo
6 grams gelatine per day for 14 days
Dietary supplement: Placebo
10 capsules daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary induced thermogenis (%)
Time Frame: 14 days
Decrease of dietary induced thermogenis after salt vs. placebo
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure (mmHg)
Time Frame: 14 days
Increase of systolic blood pressure after salt vs. placebo
14 days
Lymphocytic pro-inflammatory mediators
Time Frame: 14 days
Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo
14 days
Gut microbiome
Time Frame: 14 days
Change of gut microbiome composition after salt vs. placebo
14 days

Collaborators and Investigators

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

Sponsor

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 (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

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

Keywords

Other Study ID Numbers

  • Tissue Salt 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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