Human Sodium Balance Study

Hypertension Clinical Trial

— MEASURE  

Official title:

Sodium Regulation in Individuals on Known Dietary Sodium Intake

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04110262
• Other study ID #: HL140488
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• High dietary sodium intake
Fourteen day feeding period of high dietary sodium (3400 mg/day)
• Low dietary sodium intake
Fourteen day feeding period of low dietary sodium (2300 mg/day)

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Blood pressure	Blood pressure under high versus low dietary sodium conditions will be measured.	60 days
Secondary	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
Secondary	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