Sodium IntakeNCT05815043
Effects of Sodium Intake on Arterial Stiffness in Black Men and Women
A study testing Low-sodium intake and High-sodium intake in people with Sodium Intake and Arterial Stiffness, run by Texas State University at 1 site in United States.
Trial summary
The purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium Intake, Arterial Stiffness
- What is being tested?
- Low-sodium intake and High-sodium intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 30 Dec 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- African American or Black
- Male or Female
Who cannot join
- pregnancy or within 60 days postpartum
- having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months
- infection (viral or other) within the past 4 weeks
- having adrenal or endocrine tumors (these could impact BP)
- renal disease defined as a glomerular filtration rate (GFR) of less than 60
- prior myocardial infarction
Show all 15Show fewer
- known coronary heart disease
- personal history of stroke
- heart failure
- cardiac arrhythmias
- recent chest pain or dyspnea
- current insulin dependence
- currently undergoing chemotherapy or radiation
- identifying as transgender (the focus of this trial is biological sex)
- seated systolic or diastolic blood pressure of more than 149 mm Hg or 99 mm Hg, respectively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sodium Intake on Arterial Stiffness in Black Adults
The purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults.
- Conditions
- Sodium Intake, Arterial Stiffness
- Being tested
- Low-sodium intake, High-sodium intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sodium intakeBehavioural
Participants will consume less than or equal to 720 milligrams of sodium per day for 3 days.
High-sodium intakeDietary supplement
Participants will supplement their existing diets with 10 salt tablets daily for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Low- and high-sodium intake | Experimental | Participants will consume two different quantities of sodium per day for 3 days each. Receives: Behavioral: Low-sodium intake; Dietary Supplement: High-sodium intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-ankle vascular index
Cardio-ankle vascular index will be assessed using simultaneous arm and ankle blood pressures, EKG, and phonocardiography
Measured: This measurement will take approximately 1 minute and will be completed twice.
Ambulatory blood pressure
24-hour ambulatory blood pressure monitoring will be completed on day 3 of each dietary condition.
Measured: This measurement will take approximately 24 hours and will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Secondary outcomes (1)
Renal sodium excretion
24-hour urine samples will be analyzed for sodium concentrations and sodium excretion will be determined.
Measured: This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start13 Dec 2022
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium IntakeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815043
- Sponsor's protocol ID
- 8663
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium Intake on Arterial Stiffness in Black Adults
- ClinicalTrials.gov ID
- NCT05815043
- Acronym / sponsor ID
- 8663
- Conditions
- Sodium Intake, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Apr 2023 (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 purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low- and high-sodium intake | Experimental | Behavioral: Low-sodium intake, Dietary Supplement: High-sodium intakeParticipants will consume two different quantities of sodium per day for 3 days each. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- African American or Black
- Male or Female
Key exclusion criteria (15 listed)
- pregnancy or within 60 days postpartum
- having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months
- infection (viral or other) within the past 4 weeks
- having adrenal or endocrine tumors (these could impact BP)
- renal disease defined as a glomerular filtration rate (GFR) of less than 60
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 |
|---|---|---|
| Low-sodium intakeParticipants will consume less than or equal to 720 milligrams of sodium per day for 3 days. | Behavioural | Low- and high-sodium intake |
| High-sodium intakeParticipants will supplement their existing diets with 10 salt tablets daily for 3 days. | Dietary supplement | Low- and high-sodium intake |
Primary outcome
Cardio-ankle vascular index
Time frame: This measurement will take approximately 1 minute and will be completed twice.
Cardio-ankle vascular index will be assessed using simultaneous arm and ankle blood pressures, EKG, and phonocardiography
Ambulatory blood pressure
Time frame: This measurement will take approximately 24 hours and will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
24-hour ambulatory blood pressure monitoring will be completed on day 3 of each dietary condition.
1 secondary outcome
Renal sodium excretion
Time frame: This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-sodium intake and High-sodium intake in people with Sodium Intake and Arterial Stiffness, run by Texas State University 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 2 inclusion and 15 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 31 Jan 2025. 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?
Cardio-ankle vascular index (time frame: This measurement will take approximately 1 minute and will be completed twice.). The study lists 2 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 31 Jan 2025.