The Influence of High and Low Salt on Exosomes in the Urine

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-05-23

Brief Summary

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The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is upregulated in conditions with low salt.

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Detailed Description

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Methods:

Exosomes will be isolated from spot urine by ultracentrifugation and tested using western blotting. In-house developed antibodies against different parts of the ENaC gamma subunit as well as commercial antibodies will be used. A marker for exosomes will validate the presence of exosomes in the urine.

Power considerations:

In this cross over salt-intervention study with quantification of ENaC the investigators refer to a published study regarding the sodium-chloride co-transporter (NCC) in the kidney, were rats where given aldosterone infusion or a low salt diet. In this study n=6 was sufficient to detect a 2-3 fold change in NCC in urinary exosomes. Furthermore 5 patients with primary aldosteronism had a significant increase in NCC in urinary exosomes (N. Lubbe et al, Hypertension 2012).

On the basis of this the investigators choose to test 10 persons, but are not able to make a regular power calculation.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

open label

Study Groups

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Healthy male test subjects 1-5

High salt diet followed by low salt diet

Group Type EXPERIMENTAL

High salt diet followed by low salt diet

Intervention Type DIETARY_SUPPLEMENT

High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.

Healthy male test subjects 6-10

Low salt diet followed by high salt diet

Group Type EXPERIMENTAL

Low salt diet followed by high salt diet

Intervention Type DIETARY_SUPPLEMENT

Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.

Interventions

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High salt diet followed by low salt diet

High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.

Intervention Type DIETARY_SUPPLEMENT

Low salt diet followed by high salt diet

Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy men aged 20-40
* Body Mass Index (BMI, weight/height\^2) between 18 and 25.

Exclusion Criteria

* Increased blood pressure (hypertension) or in treatment for high blood pressure
* Diabetes
* Regular medical intake
* Smoking
* Expectation of lacking cooperation or lack of understanding of the experiment
* Clinical relevant organic or systemic disease including malign disease
* Decreased kidney function

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes