Sodium Intake Modification for High Blood Pressure

Overseen By Joseph M Stock, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Psychiatric, hypertension

Disqualifiers: Cardiovascular, cancer, metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The ability of the brain to sense changing sodium levels in the blood is critical in mediating the neurohumoral responses to hypernatremia, however, the mechanisms underlying sodium sensing in humans is poorly understood. The purpose of this study is to identify key sodium-sensing regions of the human brain in older adults and determine if the Na-K-2Cl co-transporter mediates the neurohumoral response to acute hypernatremia. Completion of this project will increase our understanding of blood pressure regulation, which has major public health implications.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking psychiatric, neurological, anxiety, depression, and hypertension medications to participate in the trial.

What data supports the idea that Sodium Intake Modification for High Blood Pressure is an effective treatment?

The available research shows that sodium intake modification can be effective in managing high blood pressure, especially when patients are actively involved in the process. For example, a study found that group management, where patients support each other and receive feedback on their sodium levels, was more effective in reducing sodium intake than just receiving advice or education. Another study suggests that reducing sodium can be a simple and safe way to help manage high blood pressure, especially for those with mild cases. However, the effectiveness can be limited by how well patients stick to the diet, as seen in a study where low salt advice only slightly lowered blood pressure in patients who were already on medication. Overall, involving family and using motivational techniques can improve the success of sodium reduction as a treatment. ^{1 2 3 4 5}

What safety data exists for sodium intake modification in treating high blood pressure?

The safety data for sodium intake modification in treating high blood pressure is mixed. Some studies suggest that sodium restriction is a simple, safe, and effective therapy for hypertension, particularly as an adjunct to thiazide diuretics. However, other studies highlight challenges, such as the low adherence to sodium-restricted diets without intensive programs and the ineffectiveness of single-session dietary counseling. The SOTRUE trial showed feasibility but not significant efficacy or safety in a short-term study of older adults. Overall, while sodium reduction can lower blood pressure, more extensive studies are needed to confirm its safety and efficacy. ^{1 4 6 7 8}

Is reducing sodium intake a promising treatment for high blood pressure?

Yes, reducing sodium intake is a promising treatment for high blood pressure. It is a simple and safe way to help lower blood pressure, especially for people with mild hypertension. Studies show that eating less sodium can lead to a significant decrease in blood pressure, which can improve heart health and potentially save many lives. ^{2 4 6 7 9}

Eligibility Criteria

This trial is for adults aged 18-45 with normal blood pressure and potassium levels, who have a BMI within the range of 18.5 to 30 kg/m2. It's designed for those without any known allergies or salt sensitivity issues that affect their blood pressure.

Inclusion Criteria

I am between 18 and 45 years old.

BMI: 18.5 kg/m2 - 30 kg/m2

Blood pressure: >100/60 mmHg and <130/80 mmHg

Exclusion Criteria

I am taking medication for a psychiatric condition.

Abnormal ECG

Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L

Treatment Details

Interventions

• Dietary Intervention
• Hypertonic Saline

Trial Overview The study aims to understand how the brain detects changes in blood sodium levels and its role in controlling blood pressure. Participants will undergo dietary interventions and receive hypertonic saline to identify key brain regions involved in sodium sensing.

Participant Groups

Group I: Salt Sensitivity Assessment Experimental Treatment 1 Intervention

1 week high salt diet and 1 week low salt diet

Group II: Functional Magnetic Resonance Imaging Experimental Treatment 1 Intervention

Hypertonic saline infusion perturbation with and without NKCC2 antagonism (furosemide) to examine sodium sensing mechanisms

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Findings from Research

A study involving 12 stable hypertensive patients found that while they believed they had significantly reduced their daily sodium intake after a single dietary counseling session, objective measurements showed no actual decrease in sodium consumption.

The results suggest that one-time dietary counseling may not be effective in achieving meaningful reductions in salt intake among hypertensive patients, indicating the need for more sustained interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. Buccicone, J., McAllister, RG.[2019]

A dietary sodium intake of 2.5 to 3 grams is recommended to meet nutritional needs and reduce the risk of hospitalizations, highlighting its efficacy in managing health outcomes.

Involving both patients and their family members in the process of adopting a low sodium diet, along with using motivational interviewing techniques, significantly enhances the likelihood of successful dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we tell patients with heart failure about sodium restriction and how should we counsel them? Lennie, TA., Chung, ML., Moser, DK.[2022]

In a one-year study involving 48 hypertensive outpatients, a small-group management program that included feedback on dietary sodium levels was the most effective method for reducing sodium intake.

This group management approach outperformed both simple advice and intensive education in helping patients lower their dietary sodium, which could potentially reduce their reliance on antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salt restriction in hypertensive patients. Comparison of advice, education, and group management. Nugent, CA., Carnahan, JE., Sheehan, ET., et al.[2013]

Restricting dietary sodium is a simple, safe, and effective nonpharmacologic approach to treating mild hypertension, making it a valuable option for patients, especially those on thiazide diuretics.

Overnight urinary collections can be used to estimate sodium intake, and using chemical chloride strips can help improve patient compliance with dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium restriction in the treatment of hypertension. Luft, FC.[2004]

A low sodium diet (1 g Na daily) showed only a modest reduction in blood pressure (4 mm Hg systolic and 3 mm Hg diastolic) among 65 hypertensive patients, indicating limited efficacy for those already on medication.

Despite the modest benefits, many patients struggled with dietary compliance, as 28% still added salt to their cooking, and 55% had sodium excretion above 80 mmol, suggesting that adherence to low sodium advice is a significant challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure? Bulpitt, CJ., Daymond, M., Bulpitt, PF., et al.[2016]

Extreme changes in sodium intake can affect blood pressure in both people with normal blood pressure and those with high blood pressure, but the evidence is not strong enough to recommend a general reduction in sodium intake for everyone to prevent hypertension.

Studies show mixed results on the effectiveness of sodium restriction for managing hypertension, and many patients are unlikely to stick to a low-sodium diet without significant support, suggesting that low-sodium diets should not be the primary public health recommendation for treating high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium manipulation in the management of hypertension. The view against its general use. Logan, AG.[2019]

High sodium intake is directly linked to increased blood pressure and hypertension, with significant public health benefits from reducing sodium consumption, as even a small decrease can lead to a notable drop in blood pressure over time.

A reduction of 1.3 grams of sodium per day could prevent a rise of about 5 mm Hg in systolic blood pressure from ages 25 to 55, potentially saving 150,000 lives each year, highlighting the need for industry regulation and consumer education to lower sodium levels in diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the population burden of cardiovascular disease by reducing sodium intake: a report of the Council on Science and Public Health. Dickinson, BD., Havas, S.[2008]

The Satter House Trial of Reduced Sodium Meals (SOTRUE) showed that a low sodium meal plan for 14 days in older adults led to a reduction in seated systolic blood pressure (SBP) from 123 to 112 mmHg, indicating potential benefits for blood pressure management.

While the low sodium diet did lower SBP by 4.8 mmHg compared to a typical sodium diet, the results were not statistically significant, suggesting that further research with a larger sample size and longer duration is necessary to confirm the efficacy and safety of low sodium meals in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. Juraschek, SP., Millar, CL., Foley, A., et al.[2021]

A study involving 95 hypertensive participants showed that a low sodium diet (less than 60 mmol/day) significantly reduced blood pressure, with an average decrease of 6 mmHg in both supine and standing positions.

The study confirmed that dietary changes, including sodium restriction and adjustments in fat and fiber intake, were effectively implemented, indicating that sodium reduction plays a crucial role in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A factorial study of fat and fibre changes and sodium restriction on blood pressure of human hypertensive subjects. Sciarrone, SE., Rouse, IL., Rogers, P., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

What should we tell patients with heart failure about sodium restriction and how should we counsel them? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Salt restriction in hypertensive patients. Comparison of advice, education, and group management. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Sodium restriction in the treatment of hypertension. [2004]

5. Finland pubmed.ncbi.nlm.nih.gov

Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure? [2016]

6. Canada pubmed.ncbi.nlm.nih.gov

Sodium manipulation in the management of hypertension. The view against its general use. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Reducing the population burden of cardiovascular disease by reducing sodium intake: a report of the Council on Science and Public Health. [2008]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

A factorial study of fat and fibre changes and sodium restriction on blood pressure of human hypertensive subjects. [2019]