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High vs Low Salt Diet for High Blood Pressure
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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
Be older than 18 years old
Must not have
Resistant HTN, defined as taking ≥ 4 anti-HTN medications to control BP or uncontrolled BP despite ≥ 3 anti-HTN medications that includes a diuretic
Current use of steroids, NSAIDS, anti-inflammatories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will have participants follow different salt diets to see how their blood pressure changes. It focuses on middle-aged people from a previous study. Researchers believe that salt intake affects blood pressure through inflammation and want to understand this better.
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.
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.
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
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take 4 or more blood pressure medications, including a diuretic, but my blood pressure is still high.
Select...
I am currently taking steroids, NSAIDs, or anti-inflammatory medications.
Select...
I have a weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
High blood pressure treatments often focus on dietary modifications, such as reducing sodium intake, which can help lower blood pressure by decreasing fluid retention and reducing the volume of blood the heart needs to pump. This is particularly important for patients with salt-sensitive blood pressure, where high sodium intake can trigger an inflammatory response, leading to increased blood pressure.
Other common treatments include weight loss, which reduces the strain on the heart, and medications like diuretics, which help the kidneys remove excess sodium and water from the body. These interventions are crucial as they help manage blood pressure, reducing the risk of cardiovascular events such as heart attacks and strokes.
Sodium, lithium-countertransport and blood pressure control by nutritional intervention in 'mild' hypertension.
Sodium, lithium-countertransport and blood pressure control by nutritional intervention in 'mild' hypertension.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
894 Previous Clinical Trials
934,083 Total Patients Enrolled
Northwestern UniversityOTHER
1,633 Previous Clinical Trials
956,314 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,632 Previous Clinical Trials
2,304,479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication to manage my blood pressure.I take 4 or more blood pressure medications, including a diuretic, but my blood pressure is still high.I do not have heart, kidney, liver issues, or POTS that prevent me from following a special salt diet.I am currently taking steroids, NSAIDs, or anti-inflammatory medications.I am not on anti-HTN meds or I control my high blood pressure with up to 3 meds.I have a weakened immune system.I have a condition like Lupus, Rheumatoid Arthritis, or Multiple Sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Low Salt Diet then High Salt Diet
- Group 2: High Salt Diet then Low Salt 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.
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