Dietary Potassium/Sodium Balance for Cardiovascular Health

Overseen By Shannon L Lennon, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Hypertension, Heart disease, Diabetes, Obesity, others

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

Compensation: Varies

Number of Visits: 2

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how varying levels of dietary potassium and sodium affect the heart and blood vessels. Researchers aim to determine whether increased potassium intake can maintain blood vessel health, even with high sodium consumption. Participants will follow one of three diets: high potassium and high sodium, moderate potassium and high sodium, or moderate potassium and low sodium. Individuals who are healthy, have normal blood pressure and heart tests, and are not on special diets or medications may be suitable for this trial. As an unphased trial, it provides a unique opportunity to contribute to significant nutritional research that could enhance heart health.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you take medications for conditions like hypertension, heart disease, diabetes, or kidney disease.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that increasing potassium intake benefits heart health. For diets high in both potassium and sodium, studies have found a reduced risk of strokes and other serious heart issues. Strong evidence indicates that increasing potassium does not harm blood fats. However, excessive potassium can lead to hyperkalemia, an excess of potassium in the blood, so monitoring is necessary.

For diets with moderate potassium and high sodium, evidence suggests that adding more potassium can lower blood pressure, even with high sodium levels. While high sodium can raise blood pressure, potassium helps counteract this effect.

A diet with moderate potassium and low sodium is generally safe and effective. Reducing sodium and increasing potassium can lower the risk of heart disease and death. Studies show this combination can safely manage blood pressure without causing harm.

Overall, these dietary changes are well-tolerated and can improve heart health, but monitoring potassium levels is important, especially with high potassium intake. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the balance of dietary potassium and sodium for cardiovascular health because it offers a fresh approach to managing heart-related issues. Unlike standard treatments like medications or invasive procedures, this study focuses on dietary adjustments. The High Potassium/High Sodium diet challenges the conventional belief that high sodium is always detrimental, while the Moderate Potassium/Low Sodium and Moderate Potassium/High Sodium diets aim to find the optimal balance for heart health. These dietary interventions could provide a natural, accessible way to support cardiovascular health, potentially reducing reliance on medication.

What evidence suggests that this trial's treatments could be effective for cardiovascular health?

This trial will compare the effects of different dietary potassium and sodium balances on cardiovascular health. Research has shown that increasing potassium intake can benefit the heart by lowering blood pressure. Studies have found that a diet high in potassium and low in salt (sodium) can reduce blood pressure, which benefits heart health. Even a small increase in potassium can help, although effects may vary among individuals. Excessive salt intake is linked to a higher risk of heart disease, so balancing it with more potassium might be beneficial. For those who consume a lot of salt, adding more potassium may help protect blood vessels. Overall, diets with more potassium and less salt are considered safe and beneficial for heart health. Participants in this trial will be assigned to one of three dietary plans: a High Potassium/High Sodium diet, a Moderate Potassium/High Sodium diet, or a Moderate Potassium/Low Sodium diet, to evaluate their effects on cardiovascular health. ^{3 4 6 7 8}

Who Is on the Research Team?

Shannon L Lennon, PhD

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

This trial is for healthy adults with normal blood pressure and ECG who aren't on medication, not endurance athletes, non-smokers, not pregnant or obese (BMI under 30), without diabetes, kidney disease, special diets (like gluten-free or vegan), hypertension or heart disease history.

Inclusion Criteria

My blood pressure is within the normal range.

You are in good health with no underlying medical conditions.

normal resting ECG

Exclusion Criteria

I have kidney disease.

My BMI is 30 or higher.

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants are provided with specific diets varying in potassium and sodium levels to assess vascular effects

10 days

2 visits (in-person) on day 7 and day 10

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Potassium/High Sodium Diet
• Moderate Potassium/High Sodium Diet
• Moderate Potassium/Low Sodium Diet

Trial Overview The study tests the effects of different diets on blood vessels: one diet has moderate potassium/low sodium; another has moderate potassium/high sodium; and a third has high potassium/high sodium. It aims to see how dietary potassium affects people's vasculature when they consume a lot of salt.

How Is the Trial Designed?

Group I: Moderate Potassium/Low Sodium Experimental Treatment 1 Intervention

Subjects will be provided with a diet that is moderate in potassium and low in sodium.

Group II: Moderate Potassium/High Sodium Experimental Treatment 1 Intervention

Subjects will be provided with a diet that is moderate in potassium and high in sodium.

Group III: High Potassium/High Sodium Experimental Treatment 1 Intervention

Subjects will be provided with a diet that is high in both potassium and sodium.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

High sodium and low potassium intake in industrialized countries is linked to increased rates of hypertension, highlighting the importance of dietary balance.

Increasing potassium intake can help lower blood pressure, especially in individuals with high sodium consumption or salt sensitivity, suggesting that dietary recommendations should focus on both sodium reduction and potassium enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potassium and blood pressure, an old story, revisited]. Zisimopoulou, S., Pechère-Bertschi, A., Burnier, M.[2018]

In a study of 108 participants, reducing dietary sodium intake from 140 to 60 mmol/d while maintaining a high potassium diet led to a significant decrease in home systolic blood pressure by 2.5 mm Hg, indicating that lower sodium can effectively help manage blood pressure.

The study demonstrated that a low sodium diet (50 mmol/d) combined with high potassium intake (over 80 mmol/d) not only reduced urinary sodium levels but also increased urinary potassium, suggesting that this dietary approach could be beneficial for blood pressure control in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing dietary sodium while following a self-selected potassium-rich diet reduces blood pressure. Nowson, CA., Morgan, TO., Gibbons, C.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2071962/

Sodium and potassium intake and risk of cardiovascular ... He et al. showed that high sodium intake was a strong risk factor for congestive heart failure in overweight participants of the NHANES I follow-up study [14], ...

2. 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 ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.19487

Modifying Dietary Sodium and Potassium Intake: An End to ... In fact, one model predicted that reducing salt intake by 3 g per day could reduce yearly cardiovascular death by 50%. SALT CONSUMPTION. Salt ( ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-17582-8

Sodium, potassium intake, and all-cause mortality When potassium intake decreases, it leads to sodium retention and elevated blood pressure. The WHO proposes a daily potassium intake of at least ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07221448

Sodium vs Potassium Education to Improve Vascular Health It is known that increasing potassium intake can improve cardiovascular disease risk factors in a laboratory setting. The investigators are ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2105675

Effect of Salt Substitution on Cardiovascular Events and ... The safety outcome was clinical hyperkalemia; sudden death was also assessed as a key indicator of safety. Routine serum potassium measurements ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11027942/

Cardiovascular Benefits of Potassium-Enriched Salt ... Potassium-enriched salt significantly reduced the rates of fatal and non-fatal strokes, major cardiovascular events, and death in older adults with a history ...

8. bmj.com bmj.com/content/346/bmj.f1378

Effect of increased potassium intake on cardiovascular risk ... High quality evidence shows that increased potassium intake reduces blood pressure in people with hypertension and has no adverse effect on blood lipid ...