Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Study Overview
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Brief Summary
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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.

Official Title
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Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Conditions
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Healthy

Intervention / Treatment
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* Other: High-sodium diet 300 mmol sodium/day
* Other: Low-sodium diet 10 mmol sodium/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High sodium diet<br> | Other: High-sodium diet 300 mmol sodium/day<br>* 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.<br>|
| Experimental: Low sodium diet<br> | Other: Low-sodium diet 10 mmol sodium/day<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Day 29 (after second diet period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet | 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 | Day 29 (after second diet period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low sodium diet, high sodium diet, biomarker, aldosterone, mineralocorticoid, mineralocorticoid receptor