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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how reducing dietary salt affects heart health, particularly in individuals with high blood pressure. Participants will either follow a Sodium Reduction Intervention diet plan or maintain their usual eating habits. The researchers aim to determine if less salt improves heart and blood vessel function, potentially preventing heart disease. The study seeks individuals with high blood pressure who may notice its impact on daily life. As an unphased trial, it offers a unique opportunity to contribute to important research that could lead to healthier lifestyle recommendations for managing high blood pressure.

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 prior data suggests that this dietary sodium reduction intervention is safe for individuals with high blood pressure?

Research has shown that eating less salt can improve health, particularly for those with high blood pressure. A review of 56 studies found that reducing salt intake helped lower blood pressure, meaning most participants experienced a decrease in blood pressure when consuming less salt. Another study found that a low-salt diet reduced the risk of heart disease by about 14% over ten years.

No specific safety issues have been reported with simply eating less salt. This approach focuses on changing eating habits, and evidence suggests it is generally well-tolerated. Reducing salt intake is widely recommended for better heart health and is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sodium reduction intervention for high blood pressure because it focuses on behavioral change to lower sodium intake to less than 2,300 mg per day, aligning with the latest guidelines. Unlike standard medications that often aim to lower blood pressure through pharmaceuticals, this approach empowers individuals through dietician-led counseling and support. This method has the potential to provide long-term health benefits by addressing dietary habits directly, which could be more sustainable and holistic compared to medication alone.

What evidence suggests that dietary sodium reduction is effective for high blood pressure?

Research has shown that eating less salt can significantly lower blood pressure. A review of 56 studies found that reducing salt intake by a certain amount decreased blood pressure by 3.7/0.9 mmHg. Cutting down on salt is also a cost-effective way to lower health risks. In this trial, participants in the sodium reduction intervention arm will follow a dietician-led program to reduce sodium intake to less than 2,300 mg per day. Additionally, the DASH diet, which includes eating less salt, has been shown to reduce the risk of heart disease over ten years. These findings support the idea that eating less salt can help manage high blood pressure and improve heart health. ^{1 2 3 6 7}

Who Is on the Research Team?

Katherine T Mills, PhD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5673777/

Reduction in dietary sodium improves blood pressure and ... A meta-analysis of 56 randomized controlled studies demonstrated that decreasing sodium excretion by 100 mmol per day lowered blood pressure by 3.7/0.9 mmHg.

2. who.int who.int/news-room/fact-sheets/detail/sodium-reduction

Sodium reduction Reducing sodium intake is one of the most cost-effective ways to improve health and reduce the burden of noncommunicable diseases.

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.20544

Dietary Sodium Reduction Is Best for Reducing Blood ... In this debate, we present a rationale for why sodium reduction is central to effective public policy to reduce hypertension and prevent CVD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12008643/

Dietary sodium reduction lowers 10-year atherosclerotic ... When compared to a typical American diet, the DASH diet changed 10-year ASCVD by -5.3 % (95 % CI -9.3, -1.2). Compared to a high sodium-control ...

5. nejm.org nejm.org/doi/full/10.1056/NEJM200101043440101

Effects on Blood Pressure of Reduced Dietary Sodium and ... The reduction of sodium intake significantly lowered systolic and diastolic blood pressure in a stepwise fashion, with both the control diet and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666667725000522

Dietary sodium reduction lowers 10-year atherosclerotic ... Compared to a high sodium-control diet, the combination of both low sodium intake with DASH changed ASCVD risk by -14.1 % (95 % CI -18.6, -9.3). Conclusions.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37950918/

Effect of Dietary Sodium on Blood Pressure: A Crossover Trial Compared with the high-sodium diet, the low-sodium diet induced a decline in mean arterial pressure in 73.4% of individuals. The commonly used ...