Dietary Education for Vascular Health

Overseen By Andrea Lobene, PhD, RD, LD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Diuretics, Tobacco, Illicit drugs

Disqualifiers: Diabetes, Renal disease, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a diet high in potassium is easier to maintain and more beneficial for blood vessels than reducing salt intake. Participants receive personal guidance on either increasing potassium or decreasing sodium through food choices. Ideal candidates are generally healthy young adults who consume too much sodium and insufficient potassium. Those who typically eat more salt than recommended and wish to adjust their diet for better heart health may find this trial suitable. As an unphased trial, it offers a unique opportunity to gain personalized dietary insights for improved heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used diuretics in the past 6 months.

What prior data suggests that these dietary education interventions are safe?

Research has shown that consuming more potassium-rich foods is generally safe and well-tolerated. Studies indicate that increasing dietary potassium can lower stroke risk and enhance heart health. For instance, one study found that individuals with higher potassium intake had a 24% lower risk of stroke.

Similarly, low-sodium diets are recognized for their health benefits, particularly in reducing blood pressure. Both high-potassium and low-sodium diets can aid in managing blood pressure, especially in individuals with hypertension.

Overall, these dietary changes are typically safe for most people and are often recommended for improved heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary education treatments for vascular health because they focus on natural dietary modifications rather than medications. Unlike standard treatments that often rely on drugs to manage vascular conditions, this approach emphasizes high potassium and low sodium diets, which can naturally support heart and blood vessel health. By educating individuals on these dietary changes, there is potential to improve vascular health with fewer side effects and empower patients to take control of their own health through everyday food choices.

What evidence suggests that this trial's dietary education treatments could be effective for improving vascular health?

This trial will compare high potassium dietary education with low sodium dietary education. Research has shown that consuming foods high in potassium can significantly improve blood vessel health. Studies have found a link between increased potassium intake and a reduction in strokes and heart problems. Potassium helps lower blood pressure, indicating a healthy heart. Reducing salt intake also benefits blood vessels, but some studies suggest potassium might be even more beneficial. Overall, both dietary changes are promising, with potassium potentially offering a slight advantage in enhancing heart health. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrea Lobene, PhD, RD, LD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for generally healthy young adults who often eat more salt than recommended. Participants will learn how to change their diet to either high potassium or low sodium and must be willing to attend weekly education sessions and follow the diet plan.

Inclusion Criteria

Usual sodium intake ≥3,000 mg/d for females and ≥4,000 mg/d for males

Usual potassium intake ≤2,500 mg/d in females and ≤3,000 mg/d in males

I can go to the lab for visits in person.

Exclusion Criteria

Elevated blood lipids (LDL cholesterol ≥190 mg/dL)

Elevated serum potassium level (>5.1 mmol/L)

Elevated BUN (>22 mg/dL)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive individualized nutrition education over four weeks to adopt either a high-potassium or low-sodium diet

4 weeks

4 visits (in-person or virtual)

Dietary Change

Participants implement dietary changes based on education received, with follow-up assessments

6 months

Follow-up assessments at 2, 4, and 6 months

Follow-up

Participants are monitored for compliance and changes in cardiovascular health post-education

6 months

What Are the Treatments Tested in This Trial?

Interventions

• High potassium dietary education/counseling
• Low sodium dietary education/counseling

Trial Overview

The study tests if it's easier and more effective for vascular health to increase potassium intake rather than decrease sodium intake in diets. It involves one-on-one dietary education sessions over four weeks, with follow-up assessments up to six months later.

How Is the Trial Designed?

Group I: High potassium dietary education Experimental Treatment 1 Intervention

Group II: Low sodium dietary education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07221448

Sodium vs Potassium Education to Improve Vascular Health

The goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4083820/

Dietary Potassium: a Key Mediator of the Cardiovascular ...

Studies have demonstrated the beneficial effects of high potassium diet on clinical cardiovascular endpoints. ... Thus, dietary potassium may have ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0735109710049764

Potassium Intake, Stroke, and Cardiovascular Disease

Higher dietary potassium intake is associated with lower rates of stroke and might also reduce the risk of CHD and total CVD.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10759559/

Effect of low sodium and high potassium diet on lowering ...

The study revealed that potassium intake and the Na:K ratio were more reliable predictors of cardiovascular outcomes [128]. The PURE study also ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03809884

Dietary Counseling or Potassium Supplement to Increase ...

Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.20545

Blood Pressure Control Should Focus on More Potassium

The meta-analysis from Aburto et al also reported a 24% lower risk of stroke (relative risk, 0.76 [95% CI, 0.66–0.89]) with high potassium ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831322011279

Potassium and Health

Adequate dietary potassium is important for heart and bone health and reduces the risk of stroke and coronary heart disease.

8.

clinicalhypertension.biomedcentral.com

clinicalhypertension.biomedcentral.com/articles/10.1186/s40885-023-00259-0

Effect of low sodium and high potassium diet on lowering ...

The blood pressure-lowering effect of a low sodium diet and a high potassium diet has been well established, especially in hypertensive population.