Dietary Sodium Reduction for High Blood Pressure

(SOLVE Trial)

Overseen By Marigny Bostock, MA, CHES

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

256 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed mechanistic trial will test the effect of dietary sodium reduction on cardiac and vascular structure and function in those with elevated blood pressure or hypertension. Findings from this study will fill the knowledge gap on the underlying mechanisms of dietary sodium intake on cardiovascular disease risk in addition to blood pressure and could provide further evidence on sodium reduction for the prevention of cardiovascular disease.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It mentions that participants can have elevated blood pressure with or without the use of antihypertensive medications, so you may be able to continue your current treatment.

What data supports the effectiveness of the treatment Sodium Reduction Intervention for high blood pressure?

Research shows that reducing sodium in the diet can significantly lower blood pressure and help control hypertension (high blood pressure). Studies have demonstrated that sodium reduction is feasible and acceptable to patients, and it can lead to fewer medications needed and better blood pressure control. ^{1 2 3 4 5}

Is reducing dietary sodium generally safe for humans?

Research shows that reducing dietary sodium is generally safe for humans. Clinical trials have not observed any negative consequences from sodium reduction, and it may even improve the intake of other nutrients. ^{2 3 5 6 7}

How is the Sodium Reduction Intervention treatment different from other treatments for high blood pressure?

The Sodium Reduction Intervention is unique because it focuses on reducing dietary sodium intake as a non-drug approach to lower blood pressure, unlike medications that directly alter body functions. This treatment involves lifestyle changes, such as using less table salt and choosing low-sodium food products, which can be more sustainable and have no negative side effects. ^{2 3 4 5 8}

Research Team

Katherine T Mills, PhD

Principal Investigator

Tulane University

Eligibility Criteria

This trial is for men and women aged 40 or older with elevated blood pressure or hypertension. It's not suitable for those with severe kidney issues, a history of heart disease, night shift workers, recent cancer treatments, current pregnancy or breastfeeding, heavy alcohol consumers, participants in other trials, or anyone who can't meet the study requirements.

Inclusion Criteria

I am 40 years old or older.

My blood pressure is high, at or above 120/80 mmHg, with or without medication.

Exclusion Criteria

Current participation in another lifestyle intervention or drug trial

My cancer needed chemo or radiation in the last 2 years.

Other concerns regarding ability to meet trial requirements (at the discretion of the study coordinator)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Intervention

Participants undergo a 3-month intensive dietician-led behavioral intervention to reduce dietary sodium intake to <2,300 mg/day

12 weeks

Monthly visits (in-person)

Maintenance

Participants continue with a 9-month maintenance phase of the sodium reduction intervention

36 weeks

Quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Sodium Reduction Intervention

Trial Overview The trial is examining how reducing dietary sodium affects the heart and blood vessels in people with high blood pressure. The goal is to understand better how less salt intake might prevent cardiovascular diseases beyond just lowering blood pressure.

Participant Groups

Group I: sodium reduction intervention Experimental Treatment 1 Intervention

The sodium reduction intervention is a dietician-led behavioral intervention consisting of two phases, first a 3-month intensive intervention phase, followed by a 9-month maintenance phase. The overall goal of the intervention is to reduce sodium intake to \<2,300 mg per day based on the most recent guideline from the National Academies of Medicine. Both phases will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake.

Group II: Usual Diet Active Control 1 Intervention

Participants randomized to the usual diet group will receive standard care from their providers with no study intervention.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

Hypertensive patients, whether treated or untreated, can significantly benefit from reducing sodium intake, leading to lower blood pressure and potentially requiring fewer medications.

Implementing a behavior modification program can effectively help patients change their eating habits, and monitoring blood pressure and urinary sodium levels can track adherence to the dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium restriction in hypertension. Langford, HG., Schlundt, D., Levine, K.[2007]

In a study of 412 adults with pre- or stage 1 hypertension, combining a low sodium diet with the DASH diet resulted in significant reductions in systolic blood pressure (SBP), especially in individuals with higher baseline SBP levels (≥150 mm Hg), where reductions reached up to -20.8 mm Hg.

Reducing sodium intake alone also lowered SBP across all baseline levels, indicating that both dietary interventions are effective in managing blood pressure, with the most pronounced effects observed in those with higher initial blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. Juraschek, SP., Miller, ER., Weaver, CM., et al.[2022]

A sodium reduction intervention over 36-48 months led to a significant decrease in urinary sodium excretion by 24.4% among participants, indicating that education and counseling can effectively lower sodium intake.

Despite the positive effects on blood pressure, with a net decrease of 2.9 mmHg at 6 months and an overall 18% lower incidence of hypertension, only 21% of participants achieved the target sodium excretion level, suggesting that broader changes in food supply may be necessary for widespread success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. Kumanyika, SK., Cook, NR., Cutler, JA., et al.[2022]

A review of 21 studies, including 16 randomized trials, found that health and nutritional education effectively reduced salt intake among adults, which is important for lowering blood pressure and cardiovascular disease risk.

Different intervention strategies, such as nutritional education alone or combined with other methods, were successful in reducing sodium consumption, but no single approach was proven to be more effective than others, highlighting the need for tailored interventions based on individual or subpopulation needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions That Successfully Reduced Adults Salt Intake-A Systematic Review. Silva-Santos, T., Moreira, P., Rodrigues, M., et al.[2022]

Reducing dietary sodium intake by 30% to 50% is feasible and acceptable for various populations, with clinical trials showing success over periods of up to 4 years.

Nonpharmacological approaches, including sodium reduction and lifestyle changes, have effectively controlled hypertension in significant portions of trial participants without negative consequences, and sometimes even improved overall nutrient intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary sodium reduction for hypertension prevention and treatment. Elmer, PJ., Grimm, RH., Flack, J., et al.[2019]

A study involving 1170 participants in rural China found that high acceptability and adherence to reduced-sodium salt substitutes were observed, indicating potential for effective sodium reduction in this population.

Barriers to using salt substitutes included a lack of knowledge about the benefits of sodium reduction and the habitual consumption of high-sodium foods, which should be addressed in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With the Use of a Salt Substitute in Rural China. Liu, Y., Chu, H., Peng, K., et al.[2022]

A systematic review of 32 randomized clinical trials involving 2635 subjects found that reducing sodium intake significantly lowers blood pressure, with reductions of -4.8 mm Hg systolic and -2.5 mm Hg diastolic in hypertensive individuals.

The study indicates that lowering sodium intake does not present safety hazards and could lead to decreased cardiovascular risks in the US population, highlighting the potential public health benefits of dietary sodium reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trials of sodium reduction: an overview. Cutler, JA., Follmann, D., Allender, PS.[2022]

Hypertensive patients are strongly recommended to reduce sodium intake and follow the DASH diet, which emphasizes salt restriction and increased consumption of fruits, vegetables, calcium, and potassium to effectively lower blood pressure.

Engaging in regular aerobic exercise and reducing alcohol consumption are also highly recommended strategies for managing high blood pressure, while smoking cessation is crucial for preventing cardiovascular disease in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical inquiries. What lifestyle changes should we recommend for the patient with newly diagnosed hypertension? McDonald, KC., Blackwell, JC., Meurer, LN.[2006]

References

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

Sodium restriction in hypertension. [2007]

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

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Interventions That Successfully Reduced Adults Salt Intake-A Systematic Review. [2022]

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

Dietary sodium reduction for hypertension prevention and treatment. [2019]

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

Factors Associated With the Use of a Salt Substitute in Rural China. [2022]

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

Randomized trials of sodium reduction: an overview. [2022]

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

Clinical inquiries. What lifestyle changes should we recommend for the patient with newly diagnosed hypertension? [2006]