Healthy
Conditions
Keywords
low sodium diet, high sodium diet, biomarker, aldosterone, mineralocorticoid, mineralocorticoid receptor
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.
Interventions
OTHERHigh-sodium diet 300 mmol sodium/day
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.
OTHERLow-sodium diet 10 mmol sodium/day
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Day 15 (after first diet period) | Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet |
Countries
United States
Outcome results
None listed