Clinical Trial

Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD

Study acronym: K-HANDLE CKD
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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 (CKD, stages 3B-5). People with CKD are often advised to avoid potassium-rich foods, even though fresh fruits and vegetables are important for good health. However, potassium in processed foods (such as packaged snacks and ready-made meals) may be absorbed differently than potassium from fresh foods. This study will compare minimally processed vs. ultra-processed foods to determine how different sources of potassium affect potassium levels and help create better dietary recommendations for people with CKD. What are the study goals? The study will answer: * Does potassium from fresh foods (like fruits and vegetables) affect blood potassium differently than potassium from processed foods? * How does dietary potassium impact potassium absorption and excretion in people with CKD? Researchers will compare the effects of four diets to understand how low and normal-potassium rich diets from fresh vs. processed foods influence: * Blood potassium levels * Body composition (muscle, fat, and fluid balance) * Vascular health What will participants do? Participants will follow four different 10-day diets over the course of the study. All food will be provided at no cost. These diets are: * Minimally processed with low-potassium content * Minimally processed with normal potassium content * Ultra-processed with with low-potassium content * Ultra-processed with normal potassium content There will be 16-day breaks (washout period) between diets where participants return to their normal eating habits. During the study, participants will: * Pick up prepared meals from the research center approximately 3 times per week. * Attend checkups for weight, blood pressure, and blood tests. * Provide urine samples to track potassium levels. * Wear a comfortable, cuff-free blood pressure monitor at home. * Keep a study journal to track diet, medications, and symptoms. * Complete questionnaires about diet satisfaction and health changes.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-02; most recent amendment 2026-02-03.
Trial Details
NCT Number NCT06920914
Lead Sponsor University of Alberta
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Chronic Kidney Disease
Enrollment 48 participants
Start Date 2026-07-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-05