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Completed

NCT Number: NCT04110262

Human Sodium Balance Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dietary sodium intake

Other

Fourteen day feeding period of high dietary sodium (3400 mg/day)

Low dietary sodium intake

Other

Fourteen day feeding period of low dietary sodium (2300 mg/day)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Sodium Regulation in Individuals on Known Dietary Sodium Intake

Acronym: MEASURE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2019
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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