Human Sodium Balance Study (MEASURE)

• ClinicalTrials.gov Identifier: NCT04110262
• Recruitment Status: Recruiting
• First Posted: October 1, 2019
• Last Update Posted: December 20, 2021
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Cheryl Anderson, University of California, San Diego

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: High dietary sodium intake; Other: Low dietary sodium intake	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
• Masking: Single (Outcomes Assessor)
• Masking Description: Throughout data collection, study data collectors and the study coordinator will remain blinded to participants' exposure group.
• Primary Purpose: Basic Science
• Official Title: Sodium Regulation in Individuals on Known Dietary Sodium Intake
• Actual Study Start Date: November 10, 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

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; Twenty five day feeding period of high dietary sodium (3400 mg/day); Other: Low dietary sodium intake; Twenty five 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; Twenty five day feeding period of high dietary sodium (3400 mg/day); Other: Low dietary sodium intake; Twenty five day feeding period of low dietary sodium (2300 mg/day)

Outcome Measures

Primary Outcome Measures :

1. Estimated sodium concentration in skin and muscle [ Time Frame: 60 days ]
   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).
2. Estimated sodium concentration in bone [ Time Frame: 60 days ]
   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.
3. Concentration of sodium, potassium, and hormone regulators in excreted urine [ Time Frame: 60 days ]
   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.
4. Blood pressure [ Time Frame: 60 days ]
   Blood pressure under high versus low dietary sodium conditions will be measured.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 18-69 years old;
• Diagnosed with high blood pressure;
• Taking no more than one medication for high blood pressure;
• Currently has a primary care provider;
• Willing to eat all meals provided by the study for a total of 50 days.

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Cheryl A Anderson, PhD; 858-534-4456; c1anderson@ucsd.edu

Contact: Valerie Mercer, MPH, MA; 858-246-5560; vjmercer@ucsd.edu

Locations

United States, California

University of California, San Diego; Recruiting

San Diego, California, United States, 92093

Contact: Cheryl A Anderson, PhD 858-534-4456 c1anderson@ucsd.edu

Principal Investigator: Cheryl A Anderson, PhD

Sub-Investigator: Natalie Sweiss, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

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

More Information

• Responsible Party: Cheryl Anderson, Professor / Dean, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT04110262
• Other Study ID Numbers: HL140488
• First Posted: October 1, 2019
• Last Update Posted: December 20, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cheryl Anderson, University of California, San Diego:

Blood pressure; Sodium; Salt; Randomized controlled trial; balance; humans

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases