Dietary Potassium Liberalization for Chronic Kidney Disease

(DK-LIB Trial)

Recruiting at 1 trial location

Overseen By Rebecca Mollard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Potassium binders

Disqualifiers: Dialysis, Heart transplant, Stroke, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on potassium binding therapy, you cannot participate in the trial.

Is a potassium-rich diet safe for people with chronic kidney disease?

A potassium-rich diet can be beneficial for overall health, but for people with chronic kidney disease, there is a risk of hyperkalemia (high potassium levels in the blood), which can be dangerous. However, new treatments and careful dietary management may allow for a more liberal intake of potassium-rich foods like fruits and vegetables, while minimizing risks. ^{1 2 3 4 5}

How does the treatment of liberalized dietary potassium via fruits and vegetables differ from other treatments for chronic kidney disease?

This treatment is unique because it allows patients with chronic kidney disease to consume more potassium-rich foods like fruits and vegetables, which are generally restricted due to the risk of hyperkalemia (high potassium levels in the blood). Unlike traditional potassium-restricted diets, this approach may use new potassium-binding agents to safely manage potassium levels while providing the health benefits of a plant-rich diet. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment 'Liberalized dietary potassium via fruits and vegetables' for chronic kidney disease?

Research suggests that a more liberalized diet, including more fruits and vegetables, can provide health benefits for people with chronic kidney disease without significantly increasing the risk of high potassium levels in the blood. This is because the fiber in plant foods may help manage potassium absorption, and the alkalinizing effect of these foods can benefit kidney health. ^{1 2 4 5 7}

Who Is on the Research Team?

Dylan Mackay, PhD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with Chronic Kidney Disease, who are not on dialysis but have a certain level of kidney function and controlled blood sugar. They should have slightly elevated potassium levels but not be in advanced heart failure, recently had a heart attack or stroke, or have severe lung disease requiring oxygen.

Inclusion Criteria

Your blood potassium level is between 4.9 and 5.5 mEq/L.

My kidney function, measured by filtration rate, is low but not extremely low.

Able to communicate in English and provide written informed consent

Exclusion Criteria

In the opinion of the investigator any medical condition, uncontrolled systemic disease or concurrent illness that would decrease the study compliance or jeopardize the safety of the participant

I haven't had serious kidney issues or very high potassium levels in the last 6 months.

I have not had a heart attack or stroke in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants receive weekly supplementation of higher potassium fruit and vegetables during a 2-week run-in period

2 weeks

1 visit (in-person or virtual)

Treatment

Participants receive either liberalized or restricted dietary potassium via fruit and vegetables for 6 weeks, followed by a crossover to the alternate treatment for another 6 weeks

12 weeks

2 visits (in-person or virtual) for dietary counseling

Washout

A 2-week washout period between the two treatment phases

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liberalized dietary potassium via fruits and vegetables
• Standard dietary potassium restriction

Trial Overview The study tests if eating fruits and vegetables with different amounts of potassium affects blood potassium levels in CKD patients. It's a randomized crossover trial where participants will get home deliveries of these foods to include in their diet and then switch after some time.

How Is the Trial Designed?

Group I: Restricted dietary potassium and then liberalized potassium via fruit and vegetables Experimental Treatment 2 Interventions

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2 week run-in and then start receiving a restricted potassium treatment period, then cross-over to the liberalized potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional COVID-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet

Group II: Liberalized dietary potassium and then restricted potassium via fruit and vegetables Experimental Treatment 2 Interventions

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2-week run-in and liberalized potassium treatment period, then cross-over to the restricted potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional Coronavirus disease (COVID)-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Published Research Related to This Trial

Potassium-rich foods can offer health benefits even for individuals with declining kidney function, but there has been concern about the risk of hyperkalemia (high potassium levels).

New treatments, such as potassium binders, may allow patients with chronic kidney disease to safely consume potassium-rich diets, and clinical trials are needed to compare the effects of a potassium-liberalized diet versus a potassium-restricted diet on various health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Let Them Eat Healthy: Can Emerging Potassium Binders Help Overcome Dietary Potassium Restrictions in Chronic Kidney Disease? Sussman, EJ., Singh, B., Clegg, D., et al.[2021]

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]

A more liberalized, plant-based diet for people on hemodialysis can provide significant benefits, including improved fiber intake and potential reductions in metabolic acidosis, outweighing previously considered risks.

However, careful meal planning is essential to avoid potential pitfalls, such as the risk of anemia and managing serum potassium levels, when adopting this dietary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing potential pitfalls of a liberalized potassium diet in the hemodialysis population. Sussman-Dabach, EJ., Joshi, S., Dupuis, L., et al.[2021]

Current guidelines recommend potassium intake restriction for patients with chronic kidney disease (CKD) due to the risk of hyperkalemia, but there is insufficient strong evidence to support strict dietary limitations.

A more individualized approach to potassium intake is suggested, focusing on gradual reductions and alternative methods to lower potassium levels without eliminating fruits and vegetables, such as identifying hidden sources and using cooking techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate stepwise restriction of potassium intake to reduce risk of hyperkalemia in chronic kidney disease: A literature review. AlSahow, A.[2023]

Recent studies indicate that patients with chronic kidney disease (CKD) do not benefit from restricting potassium-rich plant foods, challenging traditional dietary guidelines.

Dietary potassium from plant sources does not significantly affect serum potassium levels, and including these foods may offer additional health benefits for CKD patients, suggesting a shift towards more inclusive dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking the Kale out of Hyperkalemia: Plant Foods and Serum Potassium in Patients With Kidney Disease. Babich, JS., Kalantar-Zadeh, K., Joshi, S.[2022]

Ingesting potassium-rich foods can lower the risk of stroke, hypertension, kidney stones, and osteoporosis, yet many people, especially those on Western diets, do not consume enough potassium.

Current dietary restrictions on potassium for individuals with reduced kidney function lack strong evidence, and new potassium-binding agents may allow for safer consumption of potassium-rich foods, suggesting a need for more research to support dietary changes that could improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium Homeostasis, Chronic Kidney Disease, and the Plant-Enriched Diets. Palmer, BF., Colbert, G., Clegg, DJ.[2022]

In a study of 212 patients with chronic kidney disease (CKD), dietary potassium intake was not associated with serum potassium levels or hyperkalemia, suggesting that potassium restriction may not be necessary for all patients.

Factors such as diabetes mellitus and metabolic acidosis were significant predictors of hyperkalemia, indicating that other clinical conditions should be considered when managing potassium levels in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does dietary potassium intake associate with hyperkalemia in patients with chronic kidney disease? Ramos, CI., González-Ortiz, A., Espinosa-Cuevas, A., et al.[2022]

Citations

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

Let Them Eat Healthy: Can Emerging Potassium Binders Help Overcome Dietary Potassium Restrictions in Chronic Kidney Disease? [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Preventing potential pitfalls of a liberalized potassium diet in the hemodialysis population. [2021]

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

Moderate stepwise restriction of potassium intake to reduce risk of hyperkalemia in chronic kidney disease: A literature review. [2023]

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

Taking the Kale out of Hyperkalemia: Plant Foods and Serum Potassium in Patients With Kidney Disease. [2022]

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

Potassium Homeostasis, Chronic Kidney Disease, and the Plant-Enriched Diets. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Does dietary potassium intake associate with hyperkalemia in patients with chronic kidney disease? [2022]