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NCT02971787 Clinical Trial

Salt Intake and Lactobacillus Abundance

Healthy Volunteers Clinical Trial

Official title:
Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02971787
Other study ID # Tissue Salt 5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date June 2017

Study information
Verified date July 2022
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Healthy men - 18 - 50 years - Body mass index 18,5 - 29,9 kg/m2 Exclusion Criteria: - Clinically relevant heart, lung, liver, and kidney disease - Current or chronic infections - Habitual intake of probiotics or dietary supplements

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotics
Day 1-21: 2 capsules per day
• Salt
Day 8-21: 10 tablets à 600 mg per day

Locations
Country Name City State
Germany Experimental and Clinical Research Center Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Mähler A, Wilck N, Rauch G, Dechend R, Müller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease of relative abundance of four lactobacillus species 14 days
Secondary Increase of systolic blood pressure 14 days
Secondary Increase of pulse wave velocity 14 days
Secondary Increase of lymphocytic pro-inflammatory mediators 14 days
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