Clinical trial NCT04168073: Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
Official title: Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: low sodium diet
high sodium diet
biomarker
aldosterone
mineralocorticoid
mineralocorticoid receptor
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-11-19
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker
timeFrame: Day 15 (after first diet period)
measure: Urinary mineralocorticoid receptor-regulated mRNA biomarker
timeFrame: Day 29 (after second diet period)
Secondary outcomes:
measure: Blood pressure
timeFrame: Day 15 (after first diet period)
measure: Blood pressure
timeFrame: Day 29 (after second diet period)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: J Brian Byrd, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: