Dietary Potassium Liberalization for Chronic Kidney Disease
(DK-LIB Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByDylan Mackay, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Must not be taking: Potassium binders
Disqualifiers: Dialysis, Heart transplant, Stroke, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12346How 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.
12467Eligibility Criteria
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
+3 more
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.
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Restricted dietary potassium and then liberalized potassium via fruit and vegetablesExperimental Treatment2 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 vegetablesExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Seven Oaks General Hospital Chronic Disease Innovation CentreWinnipeg, Canada
Health Sciences CentreWinnipeg, Canada
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Who Is Running the Clinical Trial?
University of ManitobaLead Sponsor
Dalhousie UniversityCollaborator
References
Let Them Eat Healthy: Can Emerging Potassium Binders Help Overcome Dietary Potassium Restrictions in Chronic Kidney Disease? [2021]Potassium-rich foods might provide many health benefits even to people who have declining renal function. The barrier to obtaining these health benefits has long been the concern over hyperkalemia. There are new and novel treatment options available which may enable patients with chronic kidney disease to obtain the health benefits of eating a diet that contains foods such as fruits and vegetables which are high in potassium while reducing the risk of hyperkalemia. We conclude by emphasizing the need for clinical trials with patients on hemodialysis to directly compare the current standard of care, including a potassium-restricted diet, to a potassium-liberalized diet with a potassium binder. The outcome measures would be serum potassium (
Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. [2018]Whereas the adequate intake of potassium is relatively high in healthy adults, i.e., 4.7 g per day, a dietary potassium restriction of usually less than 3 g per day is recommended in the management of patients with reduced kidney function, especially those who tend to develop hyperkalaemia including patients who are treated with angiotensin pathway modulators. Most potassium-rich foods are considered heart-healthy nutrients with high fibre, high anti-oxidant vitamins and high alkali content such as fresh fruits and vegetables; hence, the main challenge of dietary potassium management is to maintain high fibre intake and a low net fixed-acid load, because constipation and metabolic acidosis are per se major risk factors for hyperkalaemia. To achieve a careful reduction of dietary potassium load without a decrease in alkali or fibre intake, we recommend the implementation of certain pragmatic dietary interventions as follows: Improving knowledge and education about the type of foods with excess potassium (per serving or per unit of weight); identifying foods that are needed for healthy nutrition in renal patients; classification of foods based on their potassium content normalized per unit of dietary fibre; education about the use of cooking procedures (such as boiling) in order to achieve effective potassium reduction before eating; and attention to hidden sources of potassium, in particular additives in preserved foods and low-sodium salt substitutes. The present paper aims to review dietary potassium handling and gives information about practical approaches to limit potassium load in chronic kidney disease patients at risk of hyperkalaemia.
Preventing potential pitfalls of a liberalized potassium diet in the hemodialysis population. [2021]Emerging research suggests that a more liberalized diet, specifically a more plant-based diet resulting in liberalization of potassium intake, for people receiving hemodialysis is necessary and the benefits outweigh previously thought risks. If the prescribed hemodialysis diet is to be liberalized, the need to illuminate and prevent potential pitfalls of a liberalized potassium diet is warranted. This paper explores such topics as partial to full adherence to a liberalized diet and its consequences if any, the advantages of a high-fiber intake, the theoretical risk of anemia when consuming a more plant-dominant diet, the potential benefits against renal acid load and effect on metabolic acidosis with increased fruit and vegetable intake, the putative change in serum potassium levels, carbohydrate quality, and the healthfulness of meat substitutes. The benefits of a more plant-based diet for the hemodialysis population are multifold; however, the possible pitfalls of this type of diet must be reviewed and addressed upon meal planning in order to be avoided.
Moderate stepwise restriction of potassium intake to reduce risk of hyperkalemia in chronic kidney disease: A literature review. [2023]A potassium-rich diet has several cardiovascular and renal health benefits; however, it is not recommended for patients with advanced chronic kidney disease or end-stage kidney disease because of the risk of life-threatening hyperkalemia. To assess the strength of evidence supporting potassium intake restriction in chronic kidney disease, the medical literature was searched looking for the current recommended approach and for evidence in support for such an approach. There is a lack of strong evidence supporting intense restriction of dietary potassium intake. There are several ways to reduce potassium intake without depriving the patient from fruits and vegetables, such as identifying hidden sources of potassium (processed food and preservatives) and soaking or boiling food to remove potassium. An individualized and gradual reduction of dietary potassium intake in people at risk of hyperkalemia is recommended. The current potassium dietary advice in chronic kidney disease needs to be reevaluated, individualized, and gradually introduced.
Taking the Kale out of Hyperkalemia: Plant Foods and Serum Potassium in Patients With Kidney Disease. [2022]Traditionally, diets for kidney disease were low in potassium. This recommendation was based on outdated research and often wrong assumptions that do not reflect current evidence. In fact, studies conducted over the past decades show patients with CKD, including kidney failure, do not benefit from the restriction of plant foods relative to control. Generally, dietary potassium does not correlate with serum potassium, and we posit that this is due to the effects of fiber on colonic potassium absorption, the alkalinizing effect of fruits and vegetables on metabolic acidosis, and the bioavailability of dietary potassium in plant foods. Also, consumption of plant foods may provide pleiotropic benefits to patients with CKD. Emerging dietary recommendations for kidney health should be devoid of dietary potassium restrictions from plant foods so that patient-centered kidney recipes can be encouraged and promoted.
Potassium Homeostasis, Chronic Kidney Disease, and the Plant-Enriched Diets. [2022]There are data demonstrating that ingestion of potassium-rich foods reduces the incidence of stroke, hypertension, nephrolithiasis, and osteoporosis. Dietary-consumption data indicate Westernized diets are high in processed foods, high in sodium content, and low in potassium. In fact, there are data suggesting individuals are not consuming enough potassium in their diet. Although consumption of diets high in plant proteins, fruits, and vegetables-which are excellent sources of potassium-is recognized as healthy and beneficial, individuals with decrements in their kidney function have been advised to avoid these foods. In reviewing the literature that provides the rationale for potassium restriction in patients with reductions in kidney function, it appears there is little direct evidence to support the levels of restriction which are now prescribed. Additionally, there are two new potassium-binding agents which are well tolerated and have been documented to be effective in controlling serum potassium. Therefore, with the new binding agents and the lack of empirical evidence supporting the stringent dietary potassium restrictions, the authors conclude by indicating the pressing need for further research focusing on dietary liberalization of potassium in patients with reductions in kidney function to enhance overall health and well being, to provide them cardiovascular benefits, and to reduce overall risk of mortality through the incorporation of potassium-enriched foods.
Does dietary potassium intake associate with hyperkalemia in patients with chronic kidney disease? [2022]Dietary potassium restriction is a strategy to control hyperkalemia in chronic kidney disease (CKD). However, hyperkalemia may result from a combination of clinical conditions. This study aimed to investigate whether dietary potassium or the intake of certain food groups associate with serum potassium in the face of other risk factors.