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Low vs High Sodium Diet for High Blood Pressure
N/A
Recruiting
Led By Srividya Kidambi, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English speaking subjects
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial looks at how different people's bodies react to salt in order to better understand and treat salt-sensitive hypertension.
Who is the study for?
This trial is for English-speaking individuals with blood pressure levels indicating elevated BP or Stage 1 hypertension, as per the 2017 ACC/AHA guidelines. It's not suitable for those with normal or severe high blood pressure, diabetes, heart failure, liver cirrhosis, electrolyte issues, kidney disease, certain medication use (like glucocorticoids), pregnant/nursing women, bleeding disorders, heavy daily salt intake (>6000 mg/day), metallic implants presence in body including pacemakers.Check my eligibility
What is being tested?
The study investigates how a low sodium diet versus a high sodium diet affects kidney oxygenation and metabolism in people who are sensitive to salt. This could help understand why some individuals develop high blood pressure when they consume salt and lead to better diagnostic methods and treatments.See study design
What are the potential side effects?
While this trial involves dietary changes rather than medications that typically have side effects like drugs do; potential discomforts may include cravings or dissatisfaction with the assigned diets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in renal regional tissue oxygenation in response to salt intake and salt sensitivity
Secondary outcome measures
Changes in renal metabolites in response to a high sodium diet among individuals who are salt-sensitive versus insensitive
Trial Design
2Treatment groups
Active Control
Group I: Low sodium dietActive Control1 Intervention
-Subjects will be randomized to start a low sodium diet (1200 mg/day) for two weeks (this will be followed by a high sodium diet - crossover design)
Group II: high sodium dietActive Control1 Intervention
-Subjects will be randomized to start a high sodium diet (4200 mg/day) for two weeks (this will be followed by a low sodium diet - crossover design)
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,643 Total Patients Enrolled
Srividya Kidambi, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to shellfish.You are afraid of small, enclosed spaces.I have a bleeding disorder.I speak English.My blood pressure is high but not severe, according to the 2017 guidelines.You consume more than 6000 milligrams of sodium every day.You have a pacemaker or other metal implants in your body.I do not speak English.I am currently taking glucocorticoids.You are allergic to iodine-based contrast dye.Your blood pressure is too low (less than 120/80) or too high (more than 140/90).I am taking blood thinners like aspirin or clopidogrel.I have a history of kidney disease.I have a history of diabetes, heart failure, liver cirrhosis, or electrolyte issues.
Research Study Groups:
This trial has the following groups:- Group 1: Low sodium diet
- Group 2: high sodium diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become a participant in this medical experiment?
"Qualified participants for this trial must be aged 30 to 65 and have hypertension. The goal is to recruit 70 individuals in total."
Answered by AI
Are there vacancies available for this clinical trial?
"Affirmative. Clinicaltrials.gov has the most recent information about this research study which was first posted on November 1st 2021, and is still actively recruiting patients. 70 volunteers are needed from one medical centre for this trial to proceed."
Answered by AI
Does the investigation accept participants aged less than seventy-five years?
"This clinical trial is open to adults between the ages of 30 and 65. Separately, there are 54 trials for minors under 18 years old, as well as 661 studies targeting those above senior citizen age."
Answered by AI
What is the maximum number of participants accepted for this clinical trial?
"Affirmative, the information available on clinicaltrials.gov confirms that this medical investigation is presently in search of participants - it was first announced on November 1st 2021 and last updated May 23rd 2022. 70 individuals are required to partake from one participating site."
Answered by AI
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