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Human Sodium Balance Study (MEASURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110262
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Cheryl Anderson, 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.

Condition or disease Intervention/treatment Phase
Hypertension Other: High dietary sodium intake Other: Low dietary sodium intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sodium

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110262


Contacts
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Contact: Cheryl A Anderson, PhD 858-534-4456 c1anderson@ucsd.edu
Contact: Valerie Mercer, MPH, MA 858-246-5560 vjmercer@ucsd.edu

Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92093
Contact: Cheryl A Anderson, PhD    858-534-4456    c1anderson@ucsd.edu   
Principal Investigator: Cheryl A Anderson, PhD         
Sub-Investigator: Robert Bussell, PhD         
VA San Diego Healthcare System
San Diego, California, United States, 92161
Contact: Dena E Rifkin, MD    858-855-8585 ext 2784    dena.rifkin@va.gov   
Principal Investigator: Dena E Rifkin, MD         
Sub-Investigator: Joachim Ix, MD         
Sponsors and Collaborators
University of California, San Diego
San Diego Veterans Healthcare System
Investigators
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Principal Investigator: Cheryl A Anderson, PhD University of California, San Diego

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Responsible Party: Cheryl Anderson, Professor / Interim Chair, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04110262    
Other Study ID Numbers: HL140488
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheryl Anderson, University of California, San Diego:
Blood pressure
Sodium
Salt
Randomized controlled trial
balance
humans
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases