Human Sodium Balance Study

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT04110262
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2021-11-10
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Estimated sodium concentration in bone	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.
Concentration of sodium, potassium, and hormone regulators in excreted urine	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.
Blood pressure	60 days	Blood pressure under high versus low dietary sodium conditions will be measured.
Estimated sodium concentration in skin and muscle	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).

Secondary Outcome Measures

Name	Time	Method
Racial differences in concentrations of sodium in skin, muscle and bone	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.
Racial differences in concentration of urinary potassium excretion	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States