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Electrolyte

Salt Intake for High Blood Pressure Differences by Race

N/A

Recruiting

Led By Austin T Robinson, PhD

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI below 35 Kg/m2 (otherwise healthy)

Aged between 19-75

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention)

Awards & highlights

Study Summary

This trial will test if salt affects blood pressure differently in black vs white people, and if lifestyle factors play a role in these differences.

Who is the study for?

This trial is for non-smoking individuals aged 19-75 with a BMI below 35 and no history of metabolic, pulmonary, or cardiovascular diseases. Participants must have blood pressure under 150/90 mmHg and be free from conditions that limit exercise or blood donation.Check my eligibility

What is being tested?

The study investigates how dietary salt affects blood vessel function and blood pressure regulation differently in black versus white individuals. It also examines the impact of lifestyle factors like sleep, physical activity, and nutrition on these racial differences.See study design

What are the potential side effects?

Since this trial involves acute salt intake as an intervention, potential side effects may include increased thirst, swelling due to fluid retention (edema), elevated blood pressure levels, and strain on the heart or kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is under 35.

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I am between 19 and 75 years old.

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I do not have diabetes, kidney disease, lung problems, or heart and blood vessel diseases.

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I have not smoked or used tobacco in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before, 30 minutes, and one hour after soup, both conditions (high- and low- salt) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in blood biomarkers of nitric oxide bioavailability

Changes in blood pressure reactivity

Changes in circulating inflammatory cytokines

+4 more

Secondary outcome measures

Cardio-respiratory fitness

Habitual dietary intake

Mental health - depression

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High Sodium Meal (2500 mg sodium)Experimental Treatment1 Intervention

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a high sodium meal (2500 mg sodium).

Group II: Low Sodium Meal (140 mg sodium)Placebo Group1 Intervention

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a low sodium meal (140 mg sodium) which will serve as the control condition to demonstrate whether or not observed changes are due to high sodium or occur irrespective of sodium in the postprandial state.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,303 Total Patients Enrolled

1 Trials studying Racial Disparities

60 Patients Enrolled for Racial Disparities

University of DelawareOTHER

154 Previous Clinical Trials

25,111 Total Patients Enrolled

Austin T Robinson, PhDPrincipal InvestigatorAuburn University

3 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Acute Salt (sodium chloride) (Electrolyte) Clinical Trial Eligibility Overview. Trial Name: NCT04244604 — N/A

Racial Disparities Clinical Trial 2023: Acute Salt (sodium chloride) Highlights & Side Effects. Trial Name: NCT04244604 — N/A

Acute Salt (sodium chloride) (Electrolyte) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04244604 — N/A

Racial Disparities Research Study Groups: Low Sodium Meal (140 mg sodium), High Sodium Meal (2500 mg sodium)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period open for this research study?

"Affirmative. Clinicaltrials.gov displays that this research initiative, which was first published on May 1st 2021 and last updated August 31st 2022, is actively recruiting participants. The trial needs to enrol 100 individuals from 2 different sites."

Answered by AI

Is there a possibility for me to be part of this exploration?

"This medical trial is enrolling 100 individuals with hypernatremia that are aged between 19 and 75. To be considered, prospective participants must be non-smokers, have a BMI of less than 35 Kg/m2, not suffer from any metabolic or cardiovascular conditions which could restrict exercise or blood giving abilities, and possess no precluding health issues preventing them from exercising or donating blood."

Answered by AI

What is the goal of this medical exploration?

"The focus of this study, which analyses patient data before and one hour after a meal, is centered on examining changes in flow-mediated dilation (FMD). Additionally, secondary outcomes such as physical activity (measured by steps/metabolic equivalents per day), sleep duration/quality (assessed via the Pittsburgh Sleep Quality Index) and cardio-respiratory fitness are also monitored with actigraphy devices, indirect calorimetry and a Parvo TrueOne metabolic cart."

Answered by AI

Are individuals 35 years and older being enrolled in this investigation?

"As indicated by the inclusion criteria, only those between 19 and 75 can enter this trial. For younger individuals, 9 trials are open for recruitment whereas 145 accept older patients."

Answered by AI

What is the cap for participants in this research initiative?

"Affirmative. Clinicaltrials.gov has data that this trial, which originated on May 1st 2021, is still recruiting participants. A total of 100 individuals need to be recruited across two sites."

Answered by AI

Recent research and studies

HypertensionJournal

Reducing Dietary Sodium to 1000 Mg Per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow

Babcock, Matthew C., Austin T. Robinson, Kamila U. Migdal, Joseph C. Watso, Megan M. Wenner, Sean D. Stocker, and William B. Farquhar. 2019. “Reducing Dietary Sodium to 1000 Mg Per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow”. Hypertension. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/hypertensionaha.118.12074.

Applied Physiology, Nutrition, and MetabolismJournal

A High-salt Meal Does Not Augment Blood Pressure Responses During Maximal Exercise

Migdal, Kamila U., Austin T. Robinson, Joseph C. Watso, Matthew C. Babcock, Jorge M. Serrador, and William B. Farquhar. 2020. “A High-salt Meal Does Not Augment Blood Pressure Responses During Maximal Exercise”. Applied Physiology, Nutrition, and Metabolism. Canadian Science Publishing. doi:10.1139/apnm-2019-0217.

Frontiers in PhysiologyJournal

Acute Nacl Loading Reveals a Higher Blood Pressure for a Given Serum Sodium Level in African American Compared to Caucasian Adults

Wenner, Megan M., Erin P. Paul, Austin T. Robinson, William C. Rose, and William B. Farquhar. 2018. “Acute Nacl Loading Reveals a Higher Blood Pressure for a Given Serum Sodium Level in African American Compared to Caucasian Adults”. Frontiers in Physiology. Frontiers Media SA. doi:10.3389/fphys.2018.01354.

AtherosclerosisJournal