Dietary Counseling + Potassium Supplement for High Blood Pressure

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

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

High blood pressure is the leading cause of cardiovascular disease worldwide. Many medicines are available to lower blood pressures successfully, as well as many non-medical options, such as dietary changes. Some effective dietary changes include decreasing sodium and increasing potassium in the diet. A lot of focus has been on sodium intake yet; potassium intake in the diet remains low amongst adult Canadians. Excellent data exist in the published research reporting that increasing potassium intake, either as diet or even as supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke. The overall purpose of this study is to reveal the most effective way of increasing potassium, amongst participants with high blood pressure whose existing intake of potassium is low. In the first stage, participants with high blood pressure and proven low potassium intake will receive dietary counselling. If after 4 weeks, there has not been a desired increase in potassium intake, the patients will be prescribed an additional potassium supplement.

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 the combination of dietary counseling and potassium supplementation safe for managing high blood pressure?

Research suggests that dietary counseling to reduce sodium and increase potassium intake is generally safe and can help lower blood pressure. However, long-term studies are needed to confirm these findings, and individuals should consult with healthcare providers before making significant dietary changes. ^{1 2 3 4 5}

How does the treatment of dietary counseling and potassium supplements for high blood pressure differ from other treatments?

This treatment is unique because it combines dietary counseling to reduce sodium and increase potassium intake with potassium supplements, focusing on natural dietary changes rather than medication. It emphasizes a balanced sodium/potassium intake, which is particularly beneficial for those with high sodium diets, and uses group counseling to support sustainable lifestyle changes. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Dietary Counseling + Potassium Supplement for High Blood Pressure?

Research shows that dietary counseling, especially when combined with increased potassium intake, can help lower blood pressure. A study found that dietary changes, including increased potassium, led to lower blood pressure over three years, suggesting that this approach can be effective in managing high blood pressure. ^{1 3 5 9 10}

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 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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Critical behaviors in the dietary management of hypertension. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Netherlands 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. [2022]

4. England 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. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Sodium and potassium intake and blood pressure. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Potassium and blood pressure, an old story, revisited]. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of potassium supplementation on blood pressure in Chinese: a randomized, placebo-controlled trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. [2018]