HealthyNCT02823613
The Influence of High and Low Salt on Exosomes in the Urine
A study testing High salt diet followed by low salt diet and Low salt diet followed by high salt diet in people with Healthy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High salt diet followed by low salt diet and Low salt diet followed by high salt diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to 23 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged 20-40
- Body Mass Index (BMI, weight/height^2) between 18 and 25.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Healthy
- Being tested
- High salt diet followed by low salt diet, Low salt diet followed by high salt diet
- Keywords
- ENaC, Exosomes, Urinary biomarker, Salt regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High salt diet followed by low salt dietDietary supplement
High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.
Low salt diet followed by high salt dietDietary supplement
Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy male test subjects 1-5 | Experimental | High salt diet followed by low salt diet Receives: Dietary Supplement: High salt diet followed by low salt diet |
| Healthy male test subjects 6-10 | Experimental | Low salt diet followed by high salt diet Receives: Dietary Supplement: Low salt diet followed by high salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes
Semiquantitative western blotting
Measured: After 5 days on high or low salt diet
Secondary outcomes (2)
Plasma aldosterone
Concentration in plasma.
Measured: Before study start and after 5 days on high or low salt diet
Renin
Concentration in plasma.
Measured: Before study start and after 5 days on high or low salt diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion1 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Diabetes Academy, Odense University Hospital, Beckett Foundation
- Responsible party
- Principal investigator, Rikke Zachar Langkilde, University of Southern Denmark
- Investigators
- Boye L Jensen, dr.med., phd, Study director, Cardiovascular and Renal Research, Institute of Moleculare Medicine, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823613
- Sponsor's protocol ID
- RZL-SDU-IMM-CVR
- Status last verified
- Apr 2020
- First submitted
- 23 Jun 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zachar RM, Skjodt K, Marcussen N, Walter S, Toft A, Nielsen MR, Jensen BL, Svenningsen P. The epithelial sodium channel gamma-subunit is processed proteolytically in human kidney. J Am Soc Nephrol. 2015 Jan;26(1):95-106. doi: 10.1681/ASN.2013111173. Epub 2014 Jul 24.
PubMed 25060057van der Lubbe N, Jansen PM, Salih M, Fenton RA, van den Meiracker AH, Danser AH, Zietse R, Hoorn EJ. The phosphorylated sodium chloride cotransporter in urinary exosomes is superior to prostasin as a marker for aldosteronism. Hypertension. 2012 Sep;60(3):741-8. doi: 10.1161/HYPERTENSIONAHA.112.198135. Epub 2012 Jul 30.
PubMed 22851731
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of High and Low Salt on Exosomes in the Urine
- ClinicalTrials.gov ID
- NCT02823613
- Acronym / sponsor ID
- RZL-SDU-IMM-CVR
- Conditions
- Healthy
- Keywords
- ENaC, Exosomes, Urinary biomarker, Salt regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Diabetes Academy, Odense University Hospital, Beckett Foundation
- Study start
- Aug 2016
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy male test subjects 1-5 | Experimental | Dietary Supplement: High salt diet followed by low salt dietHigh salt diet followed by low salt diet |
| Healthy male test subjects 6-10 | Experimental | Dietary Supplement: Low salt diet followed by high salt dietLow salt diet followed by high salt diet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men aged 20-40
- Body Mass Index (BMI, weight/height^2) between 18 and 25.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High salt diet followed by low salt dietHigh salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days. | Dietary supplement | Healthy male test subjects 1-5 |
| Low salt diet followed by high salt dietLow salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days. | Dietary supplement | Healthy male test subjects 6-10 |
Primary outcome
Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes
Time frame: After 5 days on high or low salt diet
Semiquantitative western blotting
2 secondary outcomes
Plasma aldosterone
Time frame: Before study start and after 5 days on high or low salt diet
Renin
Time frame: Before study start and after 5 days on high or low salt diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 25060057Zachar RM, Skjodt K, Marcussen N, Walter S, Toft A, Nielsen MR, Jensen BL, Svenningsen P. The epithelial sodium channel gamma-subunit is processed proteolytically in human kidney. J Am Soc Nephrol. 2015 Jan;26(1):95-106. doi: 10.1681/ASN.2013111173. Epub 2014 Jul 24.
- Background: PubMed 22851731van der Lubbe N, Jansen PM, Salih M, Fenton RA, van den Meiracker AH, Danser AH, Zietse R, Hoorn EJ. The phosphorylated sodium chloride cotransporter in urinary exosomes is superior to prostasin as a marker for aldosteronism. Hypertension. 2012 Sep;60(3):741-8. doi: 10.1161/HYPERTENSIONAHA.112.198135. Epub 2012 Jul 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boye L Jensen, dr.med., phd study director
Cardiovascular and Renal Research, Institute of Moleculare Medicine, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High salt diet followed by low salt diet and Low salt diet followed by high salt diet in people with Healthy, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes (time frame: After 5 days on high or low salt diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823613, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.