BSALT: Increased Salt Intake in Healthy Men

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT02509962
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Slow sodium tablets	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Increased Salt Intake on Metabolic, Cardiovascular and Immunoregulatory Functions in Healthy Men
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Slow sodium tablets Increased dietary salt intake	Dietary Supplement: Slow sodium tablets; 6 g sodium chloride per day over 14 days

Outcome Measures

Primary Outcome Measures

1. Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber) [Change to baseline at day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Michael Boschmann, Dr., Charite University, Berlin, Germany

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: NCT02509962
• Other Study ID Numbers: Tissue Salt 3
• First Posted: Jul 28, 2015
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Anja Maehler, Principle Investigator, Charite University, Berlin, Germany: Energy metabolism; Glucose tolerance; Blood pressure; Immunoregulation

Study Results

No Results Posted as of Jul 11, 2022