HypertensionMEASURENCT04110262
Human Sodium Balance Study
A study testing High dietary sodium intake and Low dietary sodium intake in people with Hypertension, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- High dietary sodium intake and Low dietary sodium intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes;
- Smoker;
- Serious food allergies;
- Currently pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Sodium Regulation in Individuals on Known Dietary Sodium Intake
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.
- Conditions
- Hypertension
- Being tested
- High dietary sodium intake, Low dietary sodium intake
- Keywords
- Blood pressure, Sodium, Salt, Randomized controlled trial, balance, humans
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dietary sodium intakeOther
Fourteen day feeding period of high dietary sodium (3400 mg/day)
Low dietary sodium intakeOther
Fourteen day feeding period of low dietary sodium (2300 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| High-low dietary sodium | Experimental | High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period Receives: Other: High dietary sodium intake; Other: Low dietary sodium intake |
| Low-high dietary sodium | Experimental | Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period Receives: Other: High dietary sodium intake; Other: Low dietary sodium intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days
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.
Measured: 60 days
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.
Measured: 60 days
Blood pressure
Blood pressure under high versus low dietary sodium conditions will be measured.
Measured: 60 days
Secondary outcomes (2)
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.
Measured: 60 days
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start10 Nov 2021
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Anderson, University of California, San Diego
- Investigators
- Cheryl A Anderson, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110262
- Sponsor's protocol ID
- HL140488
- Acronym
- MEASURE
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Regulation in Individuals on Known Dietary Sodium Intake
- ClinicalTrials.gov ID
- NCT04110262
- Acronym / sponsor ID
- MEASURE / HL140488
- Conditions
- Hypertension
- Keywords
- Blood pressure, Sodium, Salt, Randomized controlled trial, balance, humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
| Arm | Type | Receives |
|---|---|---|
| High-low dietary sodium | Experimental | Other: High dietary sodium intake, Other: Low dietary sodium intakeHigh sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period |
| Low-high dietary sodium | Experimental | Other: High dietary sodium intake, Other: Low dietary sodium intakeLow sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- Diabetes;
- Smoker;
- Serious food allergies;
- Currently pregnant or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dietary sodium intakeFourteen day feeding period of high dietary sodium (3400 mg/day) | Other | High-low dietary sodium, Low-high dietary sodium |
| Low dietary sodium intakeFourteen day feeding period of low dietary sodium (2300 mg/day) | Other | High-low dietary sodium, Low-high dietary sodium |
Primary outcome
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).
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.
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.
Blood pressure
Time frame: 60 days
Blood pressure under high versus low dietary sodium conditions will be measured.
2 secondary outcomes
Racial differences in concentrations of sodium in skin, muscle and bone
Time frame: 60 days
Racial differences in concentration of urinary potassium excretion
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl A Anderson, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dietary sodium intake and Low dietary sodium intake in people with Hypertension, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated sodium concentration in skin and muscle (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.