Dietary Sodium Reduction for High Blood Pressure
(SOLVE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byKatherine T Mills, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tulane University
Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others
No Placebo Group
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.
12345Is 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.
23567How 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.
23458Eligibility 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)
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: sodium reduction interventionExperimental Treatment1 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 DietActive Control1 Intervention
Participants randomized to the usual diet group will receive standard care from their providers with no study intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tulane University Office of Health ResearchNew Orleans, LA
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Who Is Running the Clinical Trial?
Tulane UniversityLead Sponsor
Johns Hopkins UniversityCollaborator
References
Sodium restriction in hypertension. [2007]Hypertensive patients, treated or untreated, benefit from sodium restriction. Need for fewer drugs, less hypokalemia if thiazide-diuretic treated, and lower blood pressures should result from successful reduction of sodium intake. A planned program using behavior modification principles can help patients make the necessary changes in their eating habits. Monitoring blood pressure and urinary sodium excretion will give evidence of adherence to the diet.
Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. [2022]Both sodium reduction and the DASH (Dietary Approaches to Stop Hypertension) diet, a diet rich in fruits, vegetables, and low-fat dairy products, and reduced in saturated fat and cholesterol, lower blood pressure. The separate and combined effects of these dietary interventions by baseline blood pressure (BP) has not been reported.
Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. [2022]Sodium reduction is efficacious for primary prevention of hypertension, but the feasibility of achieving this effect is unclear. The objective of the paper is detailed analyses of adherence to and effects of the sodium reduction intervention among overweight adults in the Trials of Hypertension Prevention, Phase II. Sodium reduction (comprehensive education and counselling about how to reduce sodium intake) was tested vs no dietary intervention (usual care) for 36-48 months. A total of 956 white and 203 black adults, ages 30-54 years, with diastolic blood pressure 83-89 mmHg, systolic blood pressure (SBP)
Interventions That Successfully Reduced Adults Salt Intake-A Systematic Review. [2022]Adequate sodium intake is important for lowering blood pressure and thus reducing cardiovascular disease risk and other complications. The aim of this review is to identify recent interventions around the world that have been successful in reducing salt intake.
Dietary sodium reduction for hypertension prevention and treatment. [2019]Nutritional-nonpharmacological approaches for the treatment and prevention of hypertension are of great interest. Sodium reduction is one of the primary methods recommended for these purposes. The general public is interested in the reduction of dietary sodium intake and has responded with a decrease in table salt use, the purchase of lowered sodium food products, and the use of food labels to help guide food purchases. Countervailing trends in the use of convenience foods and dining out increase the difficulty for individuals to lower sodium intake. Clinical trials that have used sodium reduction alone or in combination with other lifestyle therapies have demonstrated the feasibility of reducing dietary sodium intake from 30% to 50% for up to 4 years, in a variety of populations. Trials that used lifestyle and weight loss interventions have also achieved significant reductions in body weight and alcohol consumption and increases in physical activity. A variety of studies indicate that long-term sodium reduction is feasible and that it is acceptable to patients. No negative consequences of these interventions have been observed, and in some cases improvement in the intake of other nutrients has occurred. Nonpharmacological interventions have resulted in hypertension control in significant proportions of the trial populations. These studies demonstrate that the foregoing types of interventions can significantly contribute to hypertension treatment and prevention.
Factors Associated With the Use of a Salt Substitute in Rural China. [2022]Lowering sodium intake reduces blood pressure and may reduce the risk of cardiovascular diseases. The use of reduced-sodium salt (a salt substitute) may achieve sodium reduction, but its effectiveness may be associated with the context of its use.
Randomized trials of sodium reduction: an overview. [2022]We updated a previously published overview of randomized clinical trials testing the effects of reducing sodium intake. We excluded trials that had confounded designs, enrolled preadolescent study populations, tested intakes outside the usual range for the US population, or reported neither systolic nor diastolic blood pressure. Thirty-two trials with outcome data for 2635 subjects were included. Two reviewers abstracted information independently and differences were reconciled. Pooled blood pressure differences between treated and control groups were highly significant for all trials combined and for trials in hypertensive and normotensive subjects pooled separately. The effects on blood pressure of lowering sodium in hypertensive and normotensive subjects, respectively (each trial weighted according to sample size), were -4.8/-2.5 and -1.9/-1.1 mm Hg (systolic/diastolic). Median differences in sodium excretion between sodium-reduction and control groups in these subgroups were -77 and -76 mmol/24 h, respectively. Weighted linear-regression analyses across the trials showed dose responses, which were more consistent for trials in normotensive subjects. These associations were, per 100 mmol Na/24 h, -5.8/-2.5 and -2.3/-1.4 mm Hg in hypertensive and normotensive subjects, respectively. There is no evidence that sodium reduction as achieved in these trials presents any safety hazards. The blood pressure reduction that would result from a substantial lowering of dietary sodium in the US population could reduce cardiovascular morbidity and mortality.
Clinical inquiries. What lifestyle changes should we recommend for the patient with newly diagnosed hypertension? [2006]Hypertensive patients should reduce sodium intake (strength of recommendation [SOR]: A). The Dietary Approaches to Stop Hypertension diet (DASH diet)--with salt restriction and increased fruit, vegetable, calcium, and potassium intake-reduces blood pressure and should be recommended (SOR: A). Aerobic exercise is effective in the general, as well as elderly, populations for reducing blood pressure (SOR: A). Patients should be encouraged to reduce alcohol consumption (SOR: A). Evidence that weight loss is significantly associated with blood pressure reduction is inconclusive (SOR: C). Smoking cessation should be encouraged for all hypertensive patients for prevention of cardiovascular disease (SOR: A).