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MEASURE: Human Sodium Balance Study

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT04110262
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
15.6
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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
  • Other: High dietary sodium intake
  • Other: Low dietary sodium intake
 N/A

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Nov 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of California, San Diego San Diego California United States 92093

Sponsors and Collaborators

  • University of California, San Diego

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cheryl Anderson, Professor / Dean, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04110262
Other Study ID Numbers:
  • HL140488
First Posted:
Oct 1, 2019
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cheryl Anderson, Professor / Dean, University of California, San Diego
Blood pressure
Sodium
Salt
Randomized controlled trial
balance
humans
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Dec 20, 2021