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Search / Trial NCT06920914

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

Ckd Chronic Kidney Disease Potassium Hyperkalemia Hyperkalaemia Minimally Processed Foods Ultra Processed Foods Feeding Trial

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.

Locations

Patients applied

0 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