What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, and diuretics. ACE inhibitors and ARBs can cause side effects such as cough, elevated blood potassium levels, and kidney dysfunction. Diuretics, which help the body eliminate excess sodium and water, can lead to electrolyte imbalances, dehydration, and increased urination. These medications are generally well-tolerated but require monitoring for potential adverse effects.

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., valsartan, losartan), thiazide diuretics (e.g., hydrochlorothiazide), and calcium channel blockers (e.g., amlodipine, nifedipine). These medications help manage blood pressure by various mechanisms, such as reducing sodium retention, relaxing blood vessels, and decreasing blood volume. Dietary sodium restriction is also recommended as it can enhance the efficacy of these medications and help control blood pressure.

What other types of research exist?

Promising novel alternatives to dietary sodium intake for high blood pressure patients include: 1) Renin-angiotensin system (RAS) blockers such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are effective in reducing intraglomerular pressure and systemic blood pressure. 2) Sodium-glucose co-transporter 2 (SGLT2) inhibitors like dapagliflozin, which have shown benefits in reducing blood pressure and improving kidney outcomes. 3) Increased fluid intake to suppress plasma vasopressin levels, particularly in conditions like autosomal dominant polycystic kidney disease (ADPKD). 4) Personalized nutrition and dietary interventions tailored to individual needs, potentially incorporating innovative dietary assessment methods.

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Human Sodium Balance Study (MEASURE Trial)

N/A

Waitlist Available

Led By Cheryl A Anderson, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to eat all meals provided by the study for two 14-day feeding periods

At least 18 years old

Must not have

Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how eating different amounts of salt affects the body. It focuses on adults from various racial backgrounds to see how salt intake influences where salt is stored and its impact on blood pressure. The findings could help manage high blood pressure and related health issues.

Who is the study for?

This study is for adults aged 18-69 with high blood pressure, who are on no more than one medication for it. Participants must have a primary care provider and be willing to eat only the meals provided by the study for 50 days.

What is being tested?

The trial is exploring how different levels of dietary sodium intake (high vs. low) affect the body's handling of sodium in terms of storage and excretion, and its impact on blood pressure in a diverse group of adults.

What are the potential side effects?

While not explicitly listed, potential side effects may include changes in blood pressure or fluid balance due to varying sodium intake levels which could lead to symptoms like dizziness, swelling, or changes in urination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to eat only the meals provided by the study for two weeks.

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I am 18 years old or older.

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I take two or fewer medications for high blood pressure.

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I have been diagnosed with high blood pressure or pre-hypertension.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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

Blood pressure

Concentration of sodium, potassium, and hormone regulators in excreted urine

Estimated sodium concentration in bone

+1 more

Secondary study objectives

Racial differences in concentration of urinary potassium excretion

Bone and Bones

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-high dietary sodiumExperimental Treatment2 Interventions

Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period

Group II: High-low dietary sodiumExperimental Treatment2 Interventions

High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period

0 / 5Eligibility 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

Common treatments for high blood pressure include dietary sodium restriction, ACE inhibitors, ARBs, and diuretics. Dietary sodium restriction helps reduce blood pressure by decreasing the volume of fluid in the blood vessels, which lowers the pressure on the vessel walls. ACE inhibitors and ARBs work by relaxing blood vessels and reducing the production of angiotensin II, a hormone that narrows blood vessels. Diuretics help the kidneys remove excess sodium and water from the body, reducing blood volume and pressure. These treatments are crucial for high blood pressure patients as they help prevent complications such as heart disease, stroke, and kidney damage.

Sodium, lithium-countertransport and blood pressure control by nutritional intervention in 'mild' hypertension.