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CompletedNCT03024567TS4Updated Jul 11, 2022

Randomized Study on Salt Intake and Energy Metabolism

An interventional study of Salt and Placebo in Healthy, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Calorimetry
  • Blood pressure
  • Immunophenotyping
  • Gut microbial composition
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Clinically relevant heart, lung, liver, and kidney diseases
  • Current or chronic infection
  • Habitual use of probiotics or dietary supplements
  • Pregnancy, lactation
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Salt

    6 grams sodium chloride per day for 14 days

    Dietary Supplement: Salt

  • Placebo comparator
    Placebo

    6 grams gelatine per day for 14 days

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementSalt

    10 capsules daily for 14 days

  • Dietary supplementPlacebo

    10 capsules daily for 14 days

06

What researchers measure

Primary outcomes

  1. Dietary induced thermogenis (%)

    Decrease of dietary induced thermogenis after salt vs. placebo

    Time frame: 14 days

Secondary outcomes

  1. Systolic blood pressure (mmHg)

    Increase of systolic blood pressure after salt vs. placebo

    Time frame: 14 days

  2. Lymphocytic pro-inflammatory mediators

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

    Time frame: 14 days

  3. Gut microbiome

    Change of gut microbiome composition after salt vs. placebo

    Time frame: 14 days

07

Study locations

1 site
  • Experimental and Clinical Research Center
    Berlin, 13125, Germany
08

References and documents

Publications

  • Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253. PubMed 35057434 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03024567
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Anja Maehler (Principle Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 19, 2017
Start date
Jan 2017
Primary completion
Dec 2017
Completion
Jul 2021
Last update
Jul 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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