Potassium + Water for High Blood Pressure

(PHACKs Trial)

Overseen By Meral A Culver, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: RAAS blockers, NSAIDs, Beta-blockers, others

Disqualifiers: Pregnancy, Metabolic disease, Cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if drinking water with a potassium supplement (such as potassium chloride or potassium citrate) can improve hydration and heart health, particularly in young Black adults. High blood pressure is a concern, and Black adults often consume less potassium and are less hydrated compared to White adults. By testing this supplement, researchers aim to find better ways to support heart health and address these disparities. Suitable participants have a resting blood pressure no higher than 150/90, no metabolic or kidney diseases, and are between 18 and 30 years old. As an unphased trial, participants can contribute to groundbreaking research that may lead to better heart health solutions for their community.

Will I have to stop taking my current medications?

If you are taking certain medications that don't mix well with potassium supplements, like some blood pressure meds, pain relievers, or blood thinners, you might need to stop them to join this trial. It's best to check with the trial team to see if your specific medications are on the list.

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

Research shows that potassium supplements can affect the body in various ways. One study found that potassium chloride can help lower high blood pressure. However, excessive potassium can lead to high blood levels, known as hyperkalemia, which poses risks, especially for individuals with certain heart or kidney issues.

Another study examined the short-term use of potassium chloride in people with high blood pressure. The results suggested that potassium is generally safe, but adhering to recommended doses is crucial to avoid side effects.

Potassium is a necessary nutrient, and many people take it safely. This trial studies a specific dose (2000mg per day), so understanding the body's reaction is essential. Always consult a healthcare provider before starting any new supplement, particularly if existing health conditions are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using potassium for high blood pressure because it offers a natural approach that could complement or even reduce the need for traditional medications like ACE inhibitors or beta-blockers. Unlike these standard drugs, potassium works by helping the body balance sodium levels, which can lead to lower blood pressure. This method is appealing because it leverages the body's natural processes and may have fewer side effects compared to conventional medications. Plus, the use of potassium supplements could be a simple and cost-effective option for managing blood pressure.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research shows that increasing potassium intake can help lower blood pressure. Studies have found that people with high blood pressure who took potassium supplements experienced a drop in their blood pressure. Specifically, more potassium reduced the systolic blood pressure by about 3.49 mm Hg and the diastolic by about 1.82 to 5.15 mm Hg. Potassium is particularly effective for people who consume a lot of salt, which is common in many diets. For those not taking medication for high blood pressure, potassium supplements can be even more helpful. In this trial, participants in the "Water and Potassium" arm will receive 2000mg of potassium supplementation per day for 14 days, which might improve blood pressure and overall heart health. ^{2 3 6 7 8}

Who Is on the Research Team?

Austin T Robinson, Ph.D.

Principal Investigator

Indiana University

L. Bruce Gladden, Ph.D.

Principal Investigator

Auburn University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 with a BMI below 35, who don't have metabolic diseases like diabetes, kidney or lung issues, cardiovascular conditions, autoimmune disorders, or a history of cancer. They should also have a resting blood pressure no higher than 150/90 mmHg.

Inclusion Criteria

Resting blood pressure no higher than 150/90 mmHg

My BMI is under 35.

I do not have diabetes, kidney, lung, heart diseases, autoimmune conditions, or a history of cancer.

Exclusion Criteria

Currently pregnant or trying to become pregnant

I do not have conditions like hemophilia or take medications like Pradaxa that prevent blood donation.

I am not taking any medication that is unsafe with potassium supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Habitual Consumption

Participants are monitored after two weeks of habitual water and potassium intake prior to being assigned into the intervention phase.

2 weeks

1 visit (in-person)

Hydration Intervention

Participants receive 2000mg potassium supplementation/day for 14 days, with assessments of blood pressure, arterial stiffness, and biomarkers in urine and blood samples.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the hydration intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Potassium

Trial Overview The study tests if drinking water with added potassium (2000mg/day) can improve hydration and heart health better in Black adults compared to White adults. It involves taking urine and blood samples before and after a two-week period of this hydration strategy.

How Is the Trial Designed?

Group I: Water and Potassium Experimental Treatment 1 Intervention

N=40, 20 males, 20 females. Following the two-week habitual run-in period, this group will receive 2000mg potassium supplementation/day for 14 days. This will be achieved by taking capsules filled with potassium chloride powder.

Group II: Habitual consumption Active Control 1 Intervention

N=40, 20 males, 20 females. All participants will be monitored after two weeks of habitual water and potassium prior to being assigned into two weeks of water and potassium.

Potassium is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Potassium chloride for:

• Hypokalemia
• Cardiovascular disease prevention

Approved in European Union as Potassium chloride for:

• Hypokalemia
• Electrolyte imbalance

Approved in Canada as Potassium citrate for:

• Hypokalemia
• Kidney stone prevention

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Potassium-enriched salt substitutes can significantly lower blood pressure, with average reductions of -5.58 mm Hg for systolic and -2.88 mm Hg for diastolic pressure, making them a promising strategy for reducing sodium intake and improving heart health.

However, there is a risk of hyperkalemia, which can lead to serious heart issues, particularly in individuals with kidney problems, highlighting the need for more research on the safety and population-wide effects of these substitutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. Greer, RC., Marklund, M., Anderson, CAM., et al.[2020]

Potassium salts can effectively manage hypertension by correcting potassium loss from diuretics, lowering blood pressure through diuretic effects, and promoting vasodilation in blood vessels.

A low sodium and high potassium diet may help reduce blood pressure in many individuals with mild hypertension, but further long-term studies are needed to confirm the safety and efficacy of potassium salts as a standard treatment for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium metabolism and therapy in hypertension. Singh, RB., Singh, NK.[2017]

In a study of 20 patients with mild to moderate essential hypertension, potassium chloride supplementation did not significantly lower blood pressure compared to a placebo, despite increased urinary potassium excretion.

The findings suggest that for patients who are already moderately restricting sodium intake, doubling potassium intake through chloride salt has little to no effect on blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate potassium chloride supplementation in essential hypertension: is it additive to moderate sodium restriction? Smith, SJ., Markandu, ND., Sagnella, GA., et al.[2019]

A randomized crossover trial involving 14 hypertensive individuals found that both potassium chloride and potassium citrate significantly lowered blood pressure compared to baseline measurements, indicating that increasing potassium intake is beneficial for hypertension.

There was no significant difference in blood pressure reduction between potassium chloride and potassium citrate, suggesting that potassium can be effective in non-chloride forms, supporting the idea that consuming potassium-rich foods may similarly help lower blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. He, FJ., Markandu, ND., Coltart, R., et al.[2016]

In a study of 26 hypertensive patients on long-term chlorthalidone treatment, no significant potassium deficiency was found, suggesting that potassium loss may be compensated over time.

Potassium chloride supplements did not effectively treat hypokalaemia in these patients, as total body potassium remained unchanged and serum potassium levels showed only a minor, non-significant increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of chlorthalidone on serum and total body potassium in hypertensive patients. Leemhuis, MP., van Damme, KJ., Struyvenberg, A.[2019]

In a study involving 24 normotensive adult males, neither potassium chloride (KCl) nor potassium citrate had any significant effect on lowering blood pressure, despite confirming potassium intake through urine tests.

The results suggest that neither potassium itself nor the chloride anion plays a crucial role in reducing blood pressure under the conditions tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium effects on blood pressure: is the conjugate anion important? Mullen, JT., O'Connor, DT.[2013]

In a study of 36 male patients with high blood pressure, potassium chloride supplementation did not significantly lower overall blood pressure but effectively prevented increases in blood pressure and pulse rate when changing posture, particularly in those with low sodium excretion.

For patients with high sodium intake, potassium chloride was found to lower both systolic and diastolic blood pressure, suggesting that potassium can mitigate the blood pressure-raising effects of sodium chloride.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of potassium in control of blood pressure. Morgan, T., Teow, BH., Myers, J.[2018]

In a study of 42 patients with low potassium levels, both oral potassium chloride (KCl) and potassium citrate/bicarbonate (K-cit/bic) effectively increased serum potassium levels from an average of 3.2 mmol/l to around 4.0 mmol/l over 6 days, showing similar efficacy between the two treatments.

The study found no significant changes in blood pH, indicating that both treatments are safe in maintaining acid-base balance while correcting hypokalemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium substitution via the oral route: does its efficacy depend on the anion of the potassium salt? Meyer-Lehnert, H., Evers, WM., Krück, F.[2019]

Severe hyperkalemia, or high potassium levels, from oral potassium supplements is rare in healthy individuals but can occur in those with kidney issues or on certain medications; two cases of near-fatal hyperkalemia were reported from potassium-containing supplements, leading to cardiac arrest.

Potassium toxicity can cause serious health issues, including cardiovascular changes, muscle weakness, and gastrointestinal problems, highlighting the need for better consumer awareness and monitoring of potassium intake from over-the-counter supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life-threatening hyperkalemia from nutritional supplements: uncommon or undiagnosed? John, SK., Rangan, Y., Block, CA., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/01.hyp.0000158264.36590.19

Effect of Short-Term Supplementation of Potassium ... Randomized trials have shown that increasing potassium intake lowers blood pressure. However, most previous trials used potassium chloride, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15723964/

Effect of short-term supplementation of potassium chloride ... These blood pressures were significantly lower compared with that at baseline; however, there was no significant difference in blood pressure between potassium ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.015719

Potassium Intake and Blood Pressure: A Dose‐Response ... Among those with hypertension, potassium supplementation was on average more effective in lowering BP in participants not using antihypertensive ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322011279

Potassium and Health High dietary potassium is associated with a decrease in blood pressure, particularly in the context of a high-sodium diet.

5. bmj.com bmj.com/content/346/bmj.f1378

Effect of increased potassium intake on cardiovascular risk ... Increased potassium intake reduced systolic blood pressure by 3.49 (95% confidence interval 1.82 to 5.15) mm Hg and diastolic blood pressure by ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/potassium-citrate-oral-route/description/drg-20074773

Potassium citrate (oral route) - Side effects & dosage Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis. It is also used to prevent kidney stones that may occur with gout.

7. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21932

Potassium Magnesium Citrate Is Superior to ... KMgCit is superior to KCl, the common form of K supplement used in clinical practice, in preventing TD-induced hyperglycemia.

8. webmd.com webmd.com/drugs/2/drug-676-7058/potassium-chloride-oral/potassium-extended-release-dispersible-tablet-oral/details

Potassium Chloride (Klor-Con, K-Dur, and others) Potassium chloride can cause a high potassium level (hyperkalemia) ... high blood pressure or certain heart or kidney problems; An ...