HealthySALTYNCT04168073
Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
A study testing High-sodium diet 300 mmol sodium/day and Low-sodium diet 10 mmol sodium/day in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-sodium diet 300 mmol sodium/day and Low-sodium diet 10 mmol sodium/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 8 Dec 2021
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normotensive, as defined by:
- Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg
- Never prescribed an antihypertensive medication
- Willingness to refrain from intense exercise (for example, swimming, biking, running)
Who cannot join
- Hypertension (history of blood pressure ≥ 140/90 mmHg)
- History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
- History of chronic kidney disease
- History of heart failure
- Current food allergy
- Pregnancy
Show all 15Show fewer
- Known hyperaldosteronism
- Current mineralocorticoid antagonist use
- Current treatment for diabetes mellitus
- Known adrenal insufficiency
- Current glucocorticoid use
- Electrolyte abnormality on baseline laboratory assessment
- Current potassium supplementation
- Urinary tract infection (UTI)
- Significant renal insufficiency or any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study
Trial locations and contacts
1 site in 1 country.
About this study
This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and blood samples from each participant to study mineralocorticoid receptor-regulated mRNA biomarkers following the consumption of each diet.
The study team will instruct the participants to consume 8 days each of high- (300 mmol/day) and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two study diets will be randomly determined. In between the high- and low-sodium diets, the participants will have a wash-out period of 6 days, during which they will be encouraged to consume their usual diet. Participants will be asked to provide the study team with 24-hour urine samples, random urine samples, and blood samples throughout their participation in this clinical trial.
- Conditions
- Healthy
- Being tested
- High-sodium diet 300 mmol sodium/day, Low-sodium diet 10 mmol sodium/day
- Keywords
- low sodium diet, high sodium diet, biomarker, aldosterone, mineralocorticoid, mineralocorticoid receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-sodium diet 300 mmol sodium/dayOther
Day 7 or day 21 high-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.
Low-sodium diet 10 mmol sodium/dayOther
Day 7 or day 21 low-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.
| Study group | Role | What they receive |
|---|---|---|
| High sodium diet | Experimental | Not described Receives: Other: High-sodium diet 300 mmol sodium/day |
| Low sodium diet | Experimental | Not described Receives: Other: Low-sodium diet 10 mmol sodium/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
Measured: Day 15 (after first diet period)
Urinary mineralocorticoid receptor-regulated mRNA biomarker
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
Measured: Day 29 (after second diet period)
Secondary outcomes (2)
Blood pressure
Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet
Measured: Day 15 (after first diet period)
Blood pressure
Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet
Measured: Day 29 (after second diet period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Feb 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, J Brian Byrd, MD, MS, University of Michigan
- Investigators
- J Brian Byrd, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168073
- Sponsor's protocol ID
- HUM00097366
- Other IDs
- 1K23HL128909-01A1
- Acronym
- SALTY
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR). We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
- ClinicalTrials.gov ID
- NCT04168073
- Acronym / sponsor ID
- SALTY / HUM00097366
- Conditions
- Healthy
- Keywords
- low sodium diet, high sodium diet, biomarker, aldosterone, mineralocorticoid, mineralocorticoid receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- 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.
This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and blood samples from each participant to study mineralocorticoid receptor-regulated mRNA biomarkers following the consumption of each diet.
The study team will instruct the participants to consume 8 days each of high- (300 mmol/day) and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two study diets will be randomly determined. In between the high- and low-sodium diets, the participants will have a wash-out period of 6 days, during which they will be encouraged to consume their usual diet. Participants will be asked to provide the study team with 24-hour urine samples, random urine samples, and blood samples throughout their participation in this clinical trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High sodium diet | Experimental | Other: High-sodium diet 300 mmol sodium/day |
| Low sodium diet | Experimental | Other: Low-sodium diet 10 mmol sodium/day |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normotensive, as defined by:
- Willingness to refrain from intense exercise (for example, swimming, biking, running)
Key exclusion criteria (15 listed)
- Hypertension (history of blood pressure ≥ 140/90 mmHg)
- History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
- History of chronic kidney disease
- History of heart failure
- Current food allergy
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-sodium diet 300 mmol sodium/dayDay 7 or day 21 high-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team. | Other | High sodium diet |
| Low-sodium diet 10 mmol sodium/dayDay 7 or day 21 low-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team. | Other | Low sodium diet |
Primary outcome
Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker
Time frame: Day 15 (after first diet period)
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
Urinary mineralocorticoid receptor-regulated mRNA biomarker
Time frame: Day 29 (after second diet period)
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
2 secondary outcomes
Blood pressure
Time frame: Day 15 (after first diet period)
Blood pressure
Time frame: Day 29 (after second diet period)
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 15 Dec 2022.
- Individual participant dataSharing planned: Yes. We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR). We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.
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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.
J Brian Byrd, MD, MS principal investigator
University of Michigan
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-sodium diet 300 mmol sodium/day and Low-sodium diet 10 mmol sodium/day in people with Healthy, run by University of Michigan at 1 site in United States.
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 4 inclusion and 15 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 15 Dec 2022. 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 United States. 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?
Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker (time frame: Day 15 (after first diet period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.