Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Low-sodium diet 10 mmol sodium/day; Other: High-sodium diet 300 mmol sodium/day

• Registration Number: NCT04168073
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2020-02-12
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Status Verified: 2022-12
• Disposition First Submitted: 2022-12-06
• Disposition First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Disposition First Posted: 2022-12-15
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low sodium diet	Low-sodium diet 10 mmol sodium/day	-
High sodium diet	High-sodium diet 300 mmol sodium/day	-

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States