Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Launched by UNIVERSITY OF ALBERTA · Apr 2, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how different types of diets—specifically, minimally processed vs. ultra-processed foods—affect potassium levels and overall health in people with chronic kidney disease (CKD). Potassium is an important nutrient found in many foods, but for those with CKD, managing potassium intake can be challenging. The study aims to find out if potassium from fresh foods, like fruits and vegetables, is absorbed differently than potassium from processed foods, such as packaged snacks and ready-made meals. By comparing the effects of these diets, researchers hope to create better dietary guidelines for individuals with CKD.
To participate in this study, you need to be an adult aged 18 or older with stage 3B to stage 5 CKD who is not on dialysis. Participants will follow four different 10-day diets, with all meals provided for free, and there will be breaks in between each diet. During the study, you'll visit the research center for checkups, provide urine and stool samples, and keep a journal about your diet and health changes. This trial is not yet recruiting, but it could be a valuable opportunity to contribute to important research that may improve dietary recommendations for people with CKD.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults (≥18 years) with stage 3B-5 CKD not on dialysis.
- • Stable baseline serum potassium (≤5.5 mmol/L, ≤3 episodes of hyperkalemia in the past year)
- • Able and willing to follow a controlled feeding regimen, attend in-person visits, provide informed consent, and comply with study procedures.
- Exclusion Criteria:
- • Genetic or other unique health conditions affecting potassium handling.
- • Foreseen start of renal replacement therapy (RRT) within the next 6 months.
- • Anticipated renal replacement therapy (RRT) or preemptive kidney transplant within 6 months.
- • Acute Kidney Injury (AKI) within 3 months.
- • Kidney Failure Risk Equation (KFRE) \> 40% within 2 years.
- • History of kidney transplant.
- • Active glomerulonephritis.
- • Acute myocardial infarction (AMI) or stroke within 6 months.
- • Active cancer, autoimmune disease, or inflammatory bowel disease (IBD).
- • Ileostomy or short bowel syndrome.
- • Body mass index (BMI) \<18.5 or ≥35.
- • NYHA Class 3 or 4 congestive heart failure (CHF).
- • History of ventricular arrhythmia.
- • Recent admission to an intensive care unit (ICU), major surgery, or poorly controlled diabetes (HbA1c \>10%) in past 3 months.
- • Gastroparesis.
- • Chronic nausea and vomiting.
- • Significant psychiatric disease.
- • Uncontrolled blood pressure (above 160/100)
- • Use of immunossupressives, potassium binders, lithium, motility agents, \>2 medications that inhibit renal potassium excretion, or supplements known to influence potassium levels.
- • Fluid volume status or hypertension under active management.
- • Reliance on tube feeding or total parenteral nutrition (TPN).
- • Non-adherence to prescribed medications or therapeutic measures.
- • Pregnancy or lactation.
- • Strict dietary preferences (e.g., vegetarians, vegans) or allergies/intolerance that preclude participation in diet phases.
- • Transitioning transgender.
About University Of Alberta
The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Caroline Richard, PhD
Principal Investigator
University of Alberta
Branko Braam, MD, PhD
Principal Investigator
University of Alberta
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported