Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04168073
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
30
Enrollment
1
Location
2
Arms
21.6
Anticipated Duration (Months)
1.4
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 DiseaseIntervention/TreatmentPhase
  • Other: High-sodium diet 300 mmol sodium/day
  • Other: Low-sodium diet 10 mmol sodium/day
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 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
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/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

  1. 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).

  2. 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

  1. 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

  2. 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of MichiganAnn ArborMichiganUnited States48109

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: J Brian Byrd, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J Brian Byrd, MD, MS, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT04168073
Other Study ID Numbers:
  • HUM00097366
  • 1K23HL128909-01A1
First Posted:
Nov 19, 2019
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by J Brian Byrd, MD, MS, Assistant Professor of Internal Medicine, University of Michigan

Study Results

No Results Posted as of Oct 8, 2021