What side effects are associated with this type of intervention?

Common treatments for high blood pressure include dietary modifications, such as reducing sodium intake, which can lead to side effects like electrolyte imbalances and potential nutrient deficiencies if not managed properly. Diuretics, another common treatment, can cause dehydration, electrolyte imbalances (e.g., low potassium), and increased urination. ACE inhibitors may lead to a persistent dry cough, elevated blood potassium levels, and, in rare cases, kidney dysfunction. Calcium channel blockers can cause side effects such as dizziness, headaches, swelling in the lower extremities, and constipation. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors (e.g., enalapril, lisinopril), ARBs (e.g., losartan, valsartan), and calcium channel blockers (e.g., amlodipine). These medications help manage blood pressure by various mechanisms such as inhibiting angiotensin II production, blocking angiotensin II receptors, and relaxing blood vessels. Studies like the CARDIA trial are investigating the effects of standardized low- and high-salt diets on blood pressure and immune response, which could provide further insights into non-pharmacological interventions for hypertension management.

What other types of research exist?

Promising novel alternatives to standardized low- and high-salt diets for high blood pressure patients in 2024 include: 1) Anti-inflammatory diets, such as the DASH diet, which emphasizes fruits, vegetables, and low-fat dairy products while reducing red meat and sugar intake. 2) Plant-based diets, which have been shown to improve cardiovascular health and reduce BP. 3) Pharmacological interventions targeting the inflammatory pathways, such as IL-6 and IL-17 inhibitors. 4) Use of SGLT2 inhibitors, which have shown benefits in reducing BP and improving renal outcomes. 5) Lifestyle modifications, including regular physical activity and stress management techniques like mindfulness and yoga.

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High vs Low Salt Diet for High Blood Pressure

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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

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:

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I take 4 or more blood pressure medications, including a diuretic, but my blood pressure is still high.

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I am currently taking steroids, NSAIDs, or anti-inflammatory medications.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

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 more

Awards & 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

0 / 3Eligibility criteria met

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.