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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 Indiana 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
Must not have
History of cancer
History of cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention)
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer in the past.
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I have a history of heart disease.
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I have a history of diabetes.
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I have a history of kidney disease.
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My BMI is over 30.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in blood biomarkers of nitric oxide bioavailability
Changes in blood pressure reactivity
Changes in circulating inflammatory cytokines
+3 moreSecondary study objectives
Cardiorespiratory fitness
Habitual dietary intake
Mental health - depression
+4 moreTrial 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.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,037 Previous Clinical Trials
1,218,873 Total Patients Enrolled
Auburn UniversityLead Sponsor
79 Previous Clinical Trials
14,509 Total Patients Enrolled
1 Trials studying Racial Disparities
60 Patients Enrolled for Racial Disparities
University of DelawareOTHER
161 Previous Clinical Trials
25,542 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer in the past.I have a history of heart disease.Your blood pressure is lower than 90/50 mmHg.I don't have health issues that stop me from exercising or giving blood.I have a history of diabetes.You are a smoker or use tobacco.My BMI is under 35.I am between 19 and 75 years old.I do not have diabetes, kidney disease, lung problems, or heart and blood vessel diseases.I have a history of kidney disease.My BMI is over 30.I have not smoked or used tobacco in the last year.You are currently breastfeeding.Your blood pressure is higher than 150/90 mmHg.Your blood pressure should not be higher than 150/90 mmHg.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Low Sodium Meal (140 mg sodium)
- Group 2: High Sodium Meal (2500 mg sodium)
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