Dietary Counseling + Potassium Supplement for High Blood Pressure

No longer recruiting at 1 trial location

Overseen By Swapnil Hiremath, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Potassium supplements

Disqualifiers: Pregnancy, Severe liver disease, Cardiac disease, Uncontrolled diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 52

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to increase potassium intake in people with high blood pressure and low potassium levels. Participants first receive dietary advice from a dietitian to boost potassium intake through food. If potassium levels remain insufficient after four weeks, participants will also receive a potassium supplement (Potassium Citrate). This trial suits individuals diagnosed with high blood pressure and low potassium intake. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that if you are on certain medications like ACE inhibitors, beta-blockers, or NSAIDs, you should be on a stable dose. It's best to discuss your specific medications with the trial team.

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

Research has shown that increasing dietary potassium safely helps lower blood pressure, particularly in individuals with hypertension. Consuming potassium-rich foods is generally safe, with no major safety concerns reported.

For those needing additional potassium, potassium citrate supplements offer an option. Primarily used to treat kidney stones, these supplements are usually well-tolerated. Some studies suggest they can lower blood pressure without major side effects. However, following the recommended dosage is crucial to avoid potential issues.

In summary, studies have shown that both increasing dietary potassium and using potassium citrate supplements are safe methods for managing blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it combines personalized dietary counseling with potassium citrate supplementation to tackle high blood pressure in a unique way. Unlike standard treatments like ACE inhibitors or beta-blockers, this approach aims to naturally increase potassium intake through diet, which can help lower blood pressure. If dietary changes alone aren't enough, patients have the option to take potassium citrate supplements, providing a more natural and potentially safer alternative to traditional medications. This method not only addresses high blood pressure but also considers individual dietary habits and lifestyle, making it a personalized and holistic approach.

What evidence suggests that dietary counseling and potassium citrate supplements could be effective for high blood pressure?

This trial will compare the effects of dietary counseling and potassium citrate supplements on high blood pressure. Research has shown that both dietary advice and potassium citrate supplements can help lower high blood pressure. Participants will receive personalized eating advice from dietitians, which can reduce blood pressure and improve heart health. For those who struggle to get enough potassium from food alone, the trial includes an arm where participants receive potassium citrate supplements to further lower blood pressure. Evidence suggests that increasing potassium, whether through food or supplements, can greatly reduce the risk of heart problems like stroke. These findings strongly support using diet changes and supplements to effectively manage high blood pressure. ^{1 6 7 8 9}

Who Is on the Research Team?

Swapnil Hiremath, MD MPH

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

Adults diagnosed with high blood pressure and low potassium intake are eligible. They must be willing to undergo dietary counseling, potentially take a potassium supplement, and use effective contraception if of childbearing potential. Exclusions include severe liver disease, uncontrolled diabetes, certain heart conditions, psychiatric disorders affecting study participation, allergies to trial ingredients, abnormal blood potassium levels or kidney function.

Inclusion Criteria

I have been diagnosed with high blood pressure.

Your body is not producing enough potassium in your urine.

Provides signed and dated informed consent form

Exclusion Criteria

I am highly sensitive to potassium due to a genetic condition.

Your body's acid level is too high (pH<7.11).

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Counseling

Participants receive individually tailored dietary advice to increase potassium intake, with weekly supportive phone/email support

4 weeks

Weekly support (phone/email)

Supplementation

Participants who do not achieve desired potassium intake increase receive potassium citrate supplements

48 weeks

Regular monitoring (in-person/virtual)

Follow-up

Participants are monitored for persistence of potassium intake increase and safety measures

52 weeks

Final measurements at 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Counselling
• Potassium Citrate

Trial Overview The trial is testing whether dietary counseling alone or combined with a potassium supplement can effectively increase potassium intake in patients with high blood pressure. Initially, participants receive diet advice; those not reaching target levels after 4 weeks will also get a potassium supplement.

How Is the Trial Designed?

Group I: Dietary Counselling Experimental Treatment 1 Intervention

All enrolled patients will undergo a 1:1 counselling with a registered dietitian (with possible inclusion of family members, as appropriate). The dietitian will undertake an assessment of the comorbidities (e.g. diabetes), dietary intake, dietary habits (e.g. eating out, food preparation, socio-cultural aspects) and provide an individually tailored strategy to increase potassium in the diet. Secondly, on a weekly basis, the dietitian will contact the patient by telephone, or electronically (as preferred by the patient) to reinforce the advice and provide support/advice as necessary.

Group II: Potassium Citrate Supplement Active Control 2 Interventions

Patients who are not able to successfully increase their potassium intake at 4 weeks with dietary counselling will receive potassium citrate supplements. They will receive oral potassium supplementation in the form of 50 to 100 mmol of potassium citrate (as 25 to 50 ml of the liquid solution).

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

Approved in Canada as Dietary Counselling for:

• High Blood Pressure
• Cardiovascular Disease Prevention

Approved in United States as Dietary Counselling for:

• High Blood Pressure
• Cardiovascular Disease Prevention

Approved in European Union as Dietary Counselling for:

• High Blood Pressure
• Cardiovascular Disease Prevention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

The Hypertension Prevention Trial involved 841 participants aged 25-49, aiming to assess the impact of dietary changes on blood pressure in individuals with slightly elevated diastolic blood pressure.

Participants received structured dietary counseling focused on reducing calorie and sodium intake, and increasing potassium, which included weekly meetings and practical cooking demonstrations to help sustain these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Jeffery, RW., Tonascia, S., Bjornson-Benson, W., et al.[2019]

In a randomized trial involving 150 adults in Beijing, potassium supplementation significantly reduced systolic blood pressure by an average of 5.00 mmHg over 12 weeks, indicating its potential effectiveness in managing hypertension.

The study highlights that increasing potassium intake could be crucial for preventing and treating high blood pressure in populations with high sodium and low potassium diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of potassium supplementation on blood pressure in Chinese: a randomized, placebo-controlled trial. Gu, D., He, J., Wu, X., et al.[2022]

In a study involving 35 participants with mild to moderate hypertension, dietary counseling over 18 months led to significant reductions in blood pressure and sodium excretion compared to baseline measurements.

While serum lipids showed only temporary improvements, the study indicates that dietary counseling can be a feasible and effective intervention for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary treatment of patients with mild to moderate hypertension in a general practice: a pilot intervention study (2). Beyond three months. Koopman, H., Spreeuwenberg, C., Westerman, RF., et al.[2013]

High sodium intake combined with low potassium consumption may contribute to high blood pressure, leading to recommendations for sodium reduction in Western diets.

Moderate sodium restriction and increased potassium intake through fruits and vegetables can lower blood pressure in patients with hypertension, potentially reducing the need for medication in mild to moderate cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium and potassium intake and blood pressure. MacGregor, GA.[2019]

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 841 healthy adults over 3 years, dietary counseling led to significant reductions in sodium intake and body weight, which were associated with lower blood pressure levels compared to a control group.

The most notable blood pressure improvements were seen in the calorie reduction group, highlighting the importance of dietary changes in preventing hypertension and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hypertension Prevention Trial: three-year effects of dietary changes on blood pressure. Hypertension Prevention Trial Research Group. [2013]

Patients with reduced kidney function should limit their potassium intake to less than 3 g per day to prevent hyperkalaemia, while still maintaining a high fiber intake for overall health.

The paper suggests practical dietary interventions, such as educating patients about potassium-rich foods, using cooking methods to reduce potassium levels, and being aware of hidden potassium sources in processed foods, to help manage potassium intake effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. Cupisti, A., Kovesdy, CP., D'Alessandro, C., et al.[2018]

The report outlines 10 essential steps for patients to effectively manage their dietary habits to control high blood pressure, emphasizing a gradual and progressive approach.

Ongoing communication with the healthcare team is crucial for supporting patients in making these dietary changes, highlighting the importance of collaboration between nutrition counselors and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical behaviors in the dietary management of hypertension. Tillotson, JL., Winston, MC., Hall, Y.[2016]

Potassium supplementation significantly reduces blood pressure in non-medicated patients, with an average decrease of 4.7 mmHg for systolic blood pressure (SBP) and 3.5 mmHg for diastolic blood pressure (DBP), based on a meta-analysis of 15 trials involving 917 patients.

The effect is particularly pronounced in hypertensive patients, who experienced a reduction of 6.8 mmHg in SBP and 4.6 mmHg in DBP, indicating that increasing potassium intake, especially when combined with lower sodium intake, can be an effective strategy for managing high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily potassium intake and sodium-to-potassium ratio in the reduction of blood pressure: a meta-analysis of randomized controlled trials. Binia, A., Jaeger, J., Hu, Y., et al.[2022]

A study involving 12 stable hypertensive patients found that while they believed they had significantly reduced their daily sodium intake after a single dietary counseling session, objective measurements showed no actual decrease in sodium consumption.

The results suggest that one-time dietary counseling may not be effective in achieving meaningful reductions in salt intake among hypertensive patients, indicating the need for more sustained interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. Buccicone, J., McAllister, RG.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771610/

An Exploration of Dietary Strategies for Hypertension ... A study involving 1681 patients with hypertension found that culturally tailored dietary advice was more effective than generic dietary advice ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916524004039

Medical nutrition therapy provided by a dietitian improves ... Dietitian interventions reduced BP and related cardiovascular outcomes for adults with prehypertension or hypertension.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10551663/

DASH Diet: A Review of Its Scientifically Proven Hypertension ... During the intervention period, the DASH diet group experienced a significant decrease in systolic blood pressure by 11.8 ± 9.3 mmHg and a ...

4. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16156

Dietary Approaches to Stop Hypertension ... Hodson et al showed that a 30-day DASH intervention lowered systolic and diastolic BP in adults with normal BP but did not alter FMD compared ...

5. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/dash-diet/art-20048456

DASH diet: Healthy eating to lower your blood pressure The DASH diet is a healthy-eating plan designed to help prevent or treat high blood pressure, also called hypertension.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4366416/

Dietary Approaches to Prevent Hypertension - PMC Dietary strategies for the prevention of hypertension include reducing sodium intake, limiting alcohol consumption, increasing potassium intake, and adopting ...

7. who.int who.int/news-room/fact-sheets/detail/healthy-diet

Healthy diet High sodium intake and insufficient potassium intake contribute to high blood pressure, which in turn increases the risk of heart disease ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482514/

DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf They found that only the dietary intervention alone could decrease systolic blood pressure by about 6 to 11 mm Hg.

9. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000001031

2021 Dietary Guidance to Improve Cardiovascular Health Healthy dietary patterns are rich in potassium, which has been associated with lower blood pressure especially in people with hypertension.