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?

This trial aims to determine how consuming fruits and vegetables with varying potassium levels affects individuals with Chronic Kidney Disease (CKD). Participants will receive home-delivered produce with either higher or lower potassium content to assess its impact on blood potassium levels and overall health. The goal is to evaluate whether current dietary recommendations for potassium in CKD patients require adjustment. Individuals with CKD who manage their condition without dialysis and maintain stable blood potassium levels may be suitable candidates for the trial.

As an unphased study, this trial provides a unique opportunity to contribute to significant dietary research that could benefit CKD patients.

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

Research has shown that increasing potassium intake by eating more fruits and vegetables might be safe for people with Chronic Kidney Disease (CKD). One study found that individuals consuming about 3,500 mg of potassium from these foods did not experience major problems. There were no signs of serious side effects, indicating that this dietary change is generally well-tolerated.

However, many doctors still advise people with CKD to limit their potassium intake. This caution stems from older, less detailed research. As more studies are conducted, experts are finding that increasing potassium might not be as risky as once thought.

In summary, increasing potassium through fruits and vegetables might be safe for people with CKD, but it is crucial to follow medical advice and monitor any health changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of liberalized dietary potassium from fruits and vegetables for chronic kidney disease because it challenges traditional dietary restrictions. Unlike the standard approach, which limits potassium intake, this method promotes consuming higher-potassium fruits and veggies, potentially offering a more enjoyable and sustainable way to manage the condition. The unique feature here is the shift from restriction to inclusion, which not only could enhance dietary satisfaction but might also provide broader nutritional benefits without compromising kidney health. Additionally, the personalized dietary counseling sessions ensure that participants can integrate these changes into their current diets effectively.

What evidence suggests that this trial's treatments could be effective for Chronic Kidney Disease?

Research suggests that eating more fruits and vegetables, which are high in potassium, might benefit people with Chronic Kidney Disease (CKD). Previously, advice for CKD patients to avoid potassium was based on weak evidence. Some studies have shown that a more relaxed diet could improve overall health for those with CKD. This trial will compare two dietary approaches: one group will start with a liberalized dietary potassium intake through fruits and vegetables, followed by a restricted potassium period, while the other group will begin with a restricted potassium diet and then switch to a liberalized potassium intake. Although more research is needed, the natural benefits of fruits and vegetables might outweigh the risks of higher potassium. This potential benefit is why studies are exploring whether increasing potassium intake can be safe and helpful for CKD patients. ^{1 2 5 6 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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7406842/

Impact of Dietary Potassium Restrictions in CKD on Clinical ...

This review discusses the barriers to adherence to a low-potassium diet and the impact of dietary restrictions on adverse clinical outcomes.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05090865

Dietary Potassium Liberalization in Pre-Dialysis Patients

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 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37833679/

Dietary potassium liberalization with fruit and vegetables ...

Individuals with CKD are often told to restrict dietary potassium (K), however, this recommendation is based on low quality evidence.

4.

jrnjournal.org

jrnjournal.org/article/S1051-2276(22)00212-6/fulltext

New Insights Into Dietary Approaches to Potassium ...

Dietary potassium restriction has long been considered a core strategy for the management of chronic hyperkalemia in patients with CKD. However, ...

5.

withpower.com

withpower.com/trial/phase-kidney-diseases-2022-87783

Dietary Potassium Liberalization 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 ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590059520301096

Impact of Dietary Potassium Restrictions in CKD on Clinical ...

This review discusses the barriers to adherence to a low-potassium diet and the impact of dietary restrictions on adverse clinical outcomes.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10576319/

Dietary potassium liberalization with fruit and vegetables ...

A randomized 2-period crossover design comparing a liberalized K fruit and vegetable diet where participants will be required to consume ~ 3500 mg of dietary K ...