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High vs Low Salt Diet for High Blood Pressure

N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
We will include individuals not taking anti-HTN medications, i.e. normotensives and untreated hypertensives, and individuals with controlled HTN by use of ≤ 3 anti-HTN medications.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

Study Summary

This trial will investigate salt sensitivity of blood pressure in 500 individuals to see if there is an association with the immune response to dietary salt.

Who is the study for?
This trial is for adults who have normal blood pressure or high blood pressure that's either untreated or controlled with up to three medications. Participants must not be on certain drugs like steroids, avoid anti-inflammatory meds, and can't have conditions like heart failure or severe allergies to food.Check my eligibility
What is being tested?
The CARDIA-Salt Sensitivity of Blood Pressure study tests how a person's blood pressure changes when they switch between diets with different salt levels. It aims to understand the body's inflammatory response to salt and its effect on blood pressure in middle-aged individuals.See study design
What are the potential side effects?
There are no direct side effects mentioned for this trial since it involves dietary changes rather than medication. However, shifts in diet may affect individual health differently, potentially influencing water retention and cardiovascular strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not on anti-HTN meds or I control my high blood pressure with up to 3 meds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune response to dietary salt loading, Change in circulating levels of IL-17
Immune response to dietary salt loading, IL-10
Immune response to dietary salt loading, IL-6
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Salt Diet then High Salt DietExperimental Treatment2 Interventions
The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg). The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure.
Group II: High Salt Diet then Low Salt DietExperimental Treatment2 Interventions
The high-salt diet will be achieved through the supplementation of each participant's usual diet with Na+ bullion packets (2 packets per day). This will increase Na+ intake by approximately 2,200 mg (≈100 mEq Na+) to a total greater than 5,000 mg Na+ per day based on prior estimates of Na+ intake (see section C1.2). In addition, 1,000 mg of calcium carbonate (provided via Tums tablets) will be taken daily on the high Na+ diet to reduce the potential impact of changes in calcium intake on blood pressure. The low-salt diet is comprised of 7 days of freshly prepared frozen meals, snacks, and Na+ free water. All low-salt meals will be prepared in each site's Metabolic Kitchen, with standardization of diets across sites. The low-salt diet includes: 20 mEq Na+ (±2 mEq) (460 mg/day), 100 mEq potassium (±2 mEq), and 1,000 mg calcium (±50 mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Salt Diet
2008
Completed Phase 3
~1050

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
668,627 Total Patients Enrolled
Northwestern UniversityOTHER
1,576 Previous Clinical Trials
911,422 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,565 Previous Clinical Trials
2,267,858 Total Patients Enrolled

Media Library

High Salt Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04258332 — N/A
High Blood Pressure Research Study Groups: Low Salt Diet then High Salt Diet, High Salt Diet then Low Salt Diet
High Blood Pressure Clinical Trial 2023: High Salt Diet Highlights & Side Effects. Trial Name: NCT04258332 — N/A
High Salt Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258332 — N/A

Frequently Asked Questions

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

Are there any current openings available in this clinical investigation?

"This evidence-based evaluation has been open for recruitment since May 17, 2021. Further updates were posted on April 26th of this year and can be seen on clinicaltrials.gov."

Answered by AI

Does this research initiative offer opportunities for seniors to participate?

"To join this trial, patients must be between 50 and 70 years old. Separately, there are 136 studies for minors and 816 trials recruiting seniors."

Answered by AI

What is the highest number of participants currently enrolled in this clinical trial?

"Yes, as evidenced by the clinicaltrials.gov database, this study is currently searching for participants. It was first posted on May 17th 2021 and was last updated April 26th 2022; 500 individuals are needed across two sites to complete it."

Answered by AI

Might I be eligible to participate in this clinical research?

"This clinical trial seeks 500 adults aged between 50 and 70 who suffer from hypertension. The sole prerequisites are the willingness to comply with the study protocol, alongside being either normotensive or taking no more than 3 anti-hypertension medications."

Answered by AI
~64 spots leftby Aug 2024