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NCT Number: NCT04168073

Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

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.

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-sodium diet 300 mmol sodium/day

Other

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

Other

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.

Primary outcomes

  1. Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker

    Time frame: 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).

  2. Urinary mineralocorticoid receptor-regulated mRNA biomarker

    Time frame: 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 outcomes

  1. Blood pressure

    Time frame: Day 15 (after first diet period)

    Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet

  2. Blood pressure

    Time frame: Day 29 (after second diet period)

    Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Acronym: SALTY

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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