Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

NCT04168073 | Completed

• 2 other identifiers: HUM000973661K23HL128909-01A1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

low sodium diet; high sodium diet; biomarker; aldosterone; mineralocorticoid; mineralocorticoid receptor

Outcome Measures

Primary Outcomes (2)

• Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker

  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).

  Day 15 (after first diet period)

• Urinary mineralocorticoid receptor-regulated mRNA biomarker

  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).

  Day 29 (after second diet period)

Secondary Outcomes (2)

• Blood pressure

  Day 15 (after first diet period)

• Blood pressure

  Day 29 (after second diet period)

Study Arms (2)

High sodium diet

EXPERIMENTAL

Other: High-sodium diet 300 mmol sodium/day

Low sodium diet

EXPERIMENTAL

Other: Low-sodium diet 10 mmol sodium/day

Interventions

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.

High sodium diet

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.

Low sodium diet

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• J Brian Byrd, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: February 12, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be deposited into a repository within 1 year of the conclusion of the study.
• Access Criteria: No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.

Locations

US (1)