Randomized Study on Salt Intake and Energy Metabolism

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Salt; Dietary Supplement: Placebo

• Registration Number: NCT03024567
• Lead Sponsor: Charite University, Berlin, Germany

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Primary Completion: 2017-12
• Study Completion: 2021-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salt	Salt	6 grams sodium chloride per day for 14 days
Placebo	Placebo	6 grams gelatine per day for 14 days

Primary Outcome Measures

Name	Time	Method
Dietary induced thermogenis (%)	14 days	Decrease of dietary induced thermogenis after salt vs. placebo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany