TS4: Randomized Study on Salt Intake and Energy Metabolism

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT03024567
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Salt; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Salt 6 grams sodium chloride per day for 14 days	Dietary Supplement: Salt; 10 capsules daily for 14 days
Placebo Comparator: Placebo 6 grams gelatine per day for 14 days	Dietary Supplement: Placebo; 10 capsules daily for 14 days

Outcome Measures

Primary Outcome Measures

1. Dietary induced thermogenis (%) [14 days]

   Decrease of dietary induced thermogenis after salt vs. placebo

Secondary Outcome Measures

1. Systolic blood pressure (mmHg) [14 days]

   Increase of systolic blood pressure after salt vs. placebo

2. Lymphocytic pro-inflammatory mediators [14 days]

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

3. Gut microbiome [14 days]

   Change of gut microbiome composition after salt vs. placebo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

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

• Current or chronic infection

• Habitual use of probiotics or dietary supplements

• Pregnancy, lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Experimental and Clinical Research Center	Berlin		Germany	13125

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results publication

Publications

None provided.

• Responsible Party: Anja Maehler, Principle Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03024567
• Other Study ID Numbers: Tissue Salt 4
• First Posted: Jan 19, 2017
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anja Maehler, Principle Investigator, Charite University, Berlin, Germany: Calorimetry; Blood pressure; Immunophenotyping; Gut microbial composition

Study Results

No Results Posted as of Jul 11, 2022