Human Sodium Balance Study
- Conditions
- Hypertension
- Interventions
- Other: High dietary sodium intakeOther: Low dietary sodium intake
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- Diabetes;
- Smoker;
- Serious food allergies;
- Currently pregnant or planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High-low dietary sodium High dietary sodium intake High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period High-low dietary sodium Low dietary sodium intake High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period Low-high dietary sodium High dietary sodium intake Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period Low-high dietary sodium Low dietary sodium intake Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period
- 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.
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).
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.
- 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