Status:
NOT_YET_RECRUITING
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
What is this study about? This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (...
Eligibility Criteria
Inclusion
- Participants aged ≥18 years living with stage 3B-5 CKD (estimated glomerular filtration rate ≥ 15 mL/min/1.73m2) on conservative kidney management (not on dialysis).
- Able and willing to follow a controlled feeding regimen, attend in-person visits, provide informed consent, and comply with study procedures.
Exclusion
- General
- Pregnant or lactating women.
- Transitioning transgender individuals.
- Individuals with strict dietary preferences (e.g., vegetarians, vegans) or allergies/intolerance that would preclude participation in the diet phases.
- Kidney Function
- Foreseen start of renal replacement therapy within the next 6 months.
- Acute kidney injury in the past 3 months.
- 2-year Kidney Failure Risk Equation \> 40%.
- Preemptive kidney transplant planned within the next 6 months.
- History of kidney transplant.
- Active glomerulonephritis. Comorbidities
- Acute myocardial infarction or stroke within the past 6 months.
- Active cancer.
- Ileostomy, short bowel syndrome or inflammatory bowel disease.
- Body mass index \< 18.5 or ≥ 35.
- New York Heart Association Class III or IV congestive heart failure.
- History of ventricular arrhythmia.
- Major surgery within the past 3 months.
- Active autoimmune disease.
- Glycated hemoglobin \> 10% within the past 3 months.
- Gastroparesis.
- Chronic nausea and vomiting.
- Intensive care unit admission within the past 3 months.
- Significant psychiatric disease.
- Uncontrolled blood pressure (above 160/100). Current Use of Medications/Supplements
- Immunosuppressives.
- Potassium binders.
- Lithium.
- Motility agents.
- More than 2 medications that inhibit renal potassium excretion (e.g., angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, mineralocorticoid receptor antagonists).
- Supplements known to influence potassium levels. Potassium-Related Conditions
- Potassium \> 5.5 mmol/L in more than 3 episodes within the past year.
- Participants with genetic issues affecting potassium handling (e.g. Barter and Liddle syndrome) or other unique health conditions that could interfere with potassium handling.
- Intervention-related Conditions
- Fluid volume status or hypertension being actively managed. Other Factors
- Documented non-adherence to medications or other therapeutic measures.
- Use of tube feeding or parenteral nutrition.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06920914
Start Date
December 1 2025
End Date
June 1 2028
Last Update
November 18 2025
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