NCT03024567

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2017

Longer than P75 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

January 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

January 13, 2017

Last Update Submit

July 7, 2022

Conditions

Healthy

Keywords

CalorimetryBlood pressureImmunophenotypingGut microbial composition

Outcome Measures

Primary Outcomes (1)

  • Dietary induced thermogenis (%)

    Decrease of dietary induced thermogenis after salt vs. placebo

    14 days

Secondary Outcomes (3)

  • Systolic blood pressure (mmHg)

    14 days

  • Lymphocytic pro-inflammatory mediators

    14 days

  • Gut microbiome

    14 days

Study Arms (2)

Salt

ACTIVE COMPARATOR

6 grams sodium chloride per day for 14 days

Dietary Supplement: Salt

Placebo

PLACEBO COMPARATOR

6 grams gelatine per day for 14 days

Dietary Supplement: Placebo

Interventions

SaltDIETARY_SUPPLEMENT

10 capsules daily for 14 days

Salt
PlaceboDIETARY_SUPPLEMENT

10 capsules daily for 14 days

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35057434RESULT

MeSH Terms

Interventions

Salts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

July 1, 2021

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)