Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

University of Michigan

Status: Completed

Conditions: Healthy

Treatments: Other: Low-sodium diet 10 mmol sodium/day; Other: High-sodium diet 300 mmol sodium/day

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04168073

1K23HL128909-01A1 (U.S. NIH Grant/Contract)

HUM00097366

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

High sodium diet

Experimental group

Treatment:

Other: High-sodium diet 300 mmol sodium/day

Low sodium diet

Experimental group

Treatment:

Other: Low-sodium diet 10 mmol sodium/day