Human Sodium Balance Study (MEASURE)

Sodium Regulation in Individuals on Known Dietary Sodium Intake

The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: High dietary sodium intake; Other: Low dietary sodium intake

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old;
• Diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (SBP) > 120 mm Hg or diastolic blood pressure (DBP) > 80 mm Hg);
• Taking no more than two medications for high blood pressure;
• Currently has a primary care provider;
• Willing to eat all meals provided by the study for two 14-day feeding periods;
• Willing to complete study measurement procedures.

Exclusion Criteria:

• Diabetes;
• Smoker;
• Serious food allergies;
• Currently pregnant or planning to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-low dietary sodium; High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period	Other: High dietary sodium intake; Fourteen day feeding period of high dietary sodium (3400 mg/day); Other: Low dietary sodium intake; Fourteen day feeding period of low dietary sodium (2300 mg/day)
Experimental: Low-high dietary sodium; Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period	Other: High dietary sodium intake; Fourteen day feeding period of high dietary sodium (3400 mg/day); Other: Low dietary sodium intake; Fourteen day feeding period of low dietary sodium (2300 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated sodium concentration in skin and muscle	The concentration of sodium in skin and muscle will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Skin and muscle sodium stores will be non-invasively quantified using 23sodium-magnetic resonance imaging (23Na-MRI).	60 days
Estimated sodium concentration in bone	The concentration of sodium in bone will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Sodium storage in bone will be measured non-invasively using in vivo neutron activation analysis (IVNAA) technology to quantify the concentration of Na in the hand.	60 days
Concentration of sodium, potassium, and hormone regulators in excreted urine	Urinary concentration of sodium, potassium, and hormones (renin, angiotensin, aldosterone, free cortisol, free cortisone, glucocorticoid, and mineralocorticoid) will be measured and variation over time will be calculated.	60 days
Blood pressure	Blood pressure under high versus low dietary sodium conditions will be measured.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Racial differences in concentrations of sodium in skin, muscle and bone	Blacks/African Americans mean sodium concentrations versus the average of the means of each of the other racial/ethnic groups will be examined.	60 days
Racial differences in concentration of urinary potassium excretion	The concentration of potassium excreted in urine will be compared between Blacks/African Americans versus the pooled sample of other racial/ethnic groups.	60 days

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Cheryl A Anderson, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Blood pressure; balance; humans; Sodium; Salt
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: HL140488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No