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Human Sodium Balance Study (MEASURE)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High dietary sodium intake
Low dietary sodium intake
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring Blood pressure, Sodium, Salt, Randomized controlled trial, balance, humans

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-low dietary sodium

Low-high dietary sodium

Arm Description

High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period

Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period

Outcomes

Primary Outcome Measures

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).
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.
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.
Blood pressure
Blood pressure under high versus low dietary sodium conditions will be measured.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 23, 2019
Last Updated
December 3, 2021
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04110262
Brief Title
Human Sodium Balance Study
Acronym
MEASURE
Official Title
Sodium Regulation in Individuals on Known Dietary Sodium Intake
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, Sodium, Salt, Randomized controlled trial, balance, humans

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
Masking
Outcomes Assessor
Masking Description
Throughout data collection, study data collectors and the study coordinator will remain blinded to participants' exposure group.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-low dietary sodium
Arm Type
Experimental
Arm Description
High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period
Arm Title
Low-high dietary sodium
Arm Type
Experimental
Arm Description
Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period
Intervention Type
Other
Intervention Name(s)
High dietary sodium intake
Intervention Description
Twenty five day feeding period of high dietary sodium (3400 mg/day)
Intervention Type
Other
Intervention Name(s)
Low dietary sodium intake
Intervention Description
Twenty five day feeding period of low dietary sodium (2300 mg/day)
Primary Outcome Measure Information:
Title
Estimated sodium concentration in skin and muscle
Description
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).
Time Frame
60 days
Title
Estimated sodium concentration in bone
Description
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.
Time Frame
60 days
Title
Concentration of sodium, potassium, and hormone regulators in excreted urine
Description
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.
Time Frame
60 days
Title
Blood pressure
Description
Blood pressure under high versus low dietary sodium conditions will be measured.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Racial differences in concentrations of sodium in skin, muscle and bone
Description
Blacks/African Americans mean sodium concentrations versus the average of the means of each of the other racial/ethnic groups will be examined.
Time Frame
60 days
Title
Racial differences in concentration of urinary potassium excretion
Description
The concentration of potassium excreted in urine will be compared between Blacks/African Americans versus the pooled sample of other racial/ethnic groups.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl A Anderson, PhD
Phone
858-534-4456
Email
c1anderson@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Mercer, MPH, MA
Phone
858-246-5560
Email
vjmercer@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl A Anderson, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl A Anderson, PhD
Phone
858-534-4456
Email
c1anderson@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Cheryl A Anderson, PhD
First Name & Middle Initial & Last Name & Degree
Natalie Sweiss, MD

12. IPD Sharing Statement

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Human Sodium Balance Study

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