Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT04168073

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: High-sodium diet 300 mmol sodium/day Other: Low-sodium diet 10 mmol sodium/day	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Actual Study Start Date :

Feb 12, 2020

Actual Primary Completion Date :

Dec 8, 2021

Actual Study Completion Date :

Dec 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High sodium diet	Other: High-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.
Experimental: Low sodium diet	Other: Low-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.

Arm

Intervention/Treatment

Experimental: High sodium diet

Other: High-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.

Experimental: Low sodium diet

Other: Low-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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Blood pressure [Day 29 (after second diet period)]
Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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