7 Participants Needed

Dietary Counseling + Potassium Supplement for High Blood Pressure

Recruiting at 1 trial location
JL
JW
JB
SH
Overseen BySwapnil Hiremath, MD PhD
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.12467

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.268910

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.

Research Team

SH

Swapnil Hiremath, MD MPH

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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
See 1 more

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
See 16 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietary CounsellingExperimental Treatment1 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 SupplementActive Control2 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Findings from Research

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.
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.
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.
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]

References

Critical behaviors in the dietary management of hypertension. [2016]
The Hypertension Prevention Trial: three-year effects of dietary changes on blood pressure. Hypertension Prevention Trial Research Group. [2013]
Daily potassium intake and sodium-to-potassium ratio in the reduction of blood pressure: a meta-analysis of randomized controlled trials. [2022]
Dietary treatment of patients with mild to moderate hypertension in a general practice: a pilot intervention study (2). Beyond three months. [2013]
Failure of single-session dietary counseling to reduce salt intake in hypertensive patients. [2019]
Treatment in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. [2019]
Sodium and potassium intake and blood pressure. [2019]
[Potassium and blood pressure, an old story, revisited]. [2018]
Effect of potassium supplementation on blood pressure in Chinese: a randomized, placebo-controlled trial. [2022]
Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. [2018]
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