Randomized Study on Salt Intake and Energy Metabolism

NCT ID: NCT03024567

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Salt

6 grams sodium chloride per day for 14 days

Group Type ACTIVE_COMPARATOR

Salt

Intervention Type DIETARY_SUPPLEMENT

10 capsules daily for 14 days

Placebo

6 grams gelatine per day for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

10 capsules daily for 14 days

Interventions

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Salt

10 capsules daily for 14 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

10 capsules daily for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Anja Maehler

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Experimental and Clinical Research Center

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 35057434 (View on PubMed)

Other Identifiers

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Tissue Salt 4

Identifier Type: -

Identifier Source: org_study_id

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