Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
NCT ID: NCT04168073
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2020-02-12
2021-12-08
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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High sodium diet
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.
Low sodium diet
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
50 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
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J Brian Byrd, MD, MS
Assistant Professor of Internal Medicine
Principal Investigators
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J Brian Byrd, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HUM00097366
Identifier Type: -
Identifier Source: org_study_id