NCT02509962

Brief Summary

To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable healthy

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

July 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

July 24, 2015

Last Update Submit

July 7, 2022

Conditions

Healthy

Keywords

Energy metabolismGlucose toleranceBlood pressureImmunoregulation

Outcome Measures

Primary Outcomes (1)

  • Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber)

    Change to baseline at day 14

Study Arms (1)

Slow sodium tablets

EXPERIMENTAL

Increased dietary salt intake

Dietary Supplement: Slow sodium tablets

Interventions

Slow sodium tabletsDIETARY_SUPPLEMENT

6 g sodium chloride per day over 14 days

Slow sodium tablets

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index 18.5 - 29.9 kg/m2

You may not qualify if:

  • clinically relevant heart, lung, liver, and kidney diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (2)

  • Wilck N, Matus MG, Kearney SM, Olesen SW, Forslund K, Bartolomaeus H, Haase S, Mahler A, Balogh A, Marko L, Vvedenskaya O, Kleiner FH, Tsvetkov D, Klug L, Costea PI, Sunagawa S, Maier L, Rakova N, Schatz V, Neubert P, Fratzer C, Krannich A, Gollasch M, Grohme DA, Corte-Real BF, Gerlach RG, Basic M, Typas A, Wu C, Titze JM, Jantsch J, Boschmann M, Dechend R, Kleinewietfeld M, Kempa S, Bork P, Linker RA, Alm EJ, Muller DN. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017 Nov 30;551(7682):585-589. doi: 10.1038/nature24628. Epub 2017 Nov 15.

    PMID: 29143823RESULT

  • Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28.

    PMID: 33906377DERIVED

Related Links

Study Officials

  • Michael Boschmann, Dr.

    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

July 24, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

DE(1)