Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

Sponsor
University of Ontario Institute of Technology
Study ID
NCT07772856
Status
Not Yet Recruiting

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Conditions

  • Diet Intervention
  • End Stage Kidney Disease (ESKD)
  • Hemodialysis
  • Hyperkalemia
  • Potassium Bioavailability

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liberalized Potassium Diet — BEHAVIORAL
    For 12 weeks, the liberalized potassium diet group (n=74) will increase their intake of minimally processed foods that are higher in potassium, including fruits, vegetables, nuts, legumes and whole grains, while limiting highly processed foods rich in potassium (\>200 mg/serving) and potassium additives. The liberalized diet will provide \~2600-3000. Participants will also be counselled to use cooking techniques to reduce potassium in root vegetables. The liberalized diet will provide \~2600-3000 mg potassium daily, reflecting the mean potassium intake of Canadian adults. Participants will receive weekly individualized counselling (30-60 min) during the first 4 weeks, followed by sessions (weeks 8 \& 12), reflecting usual care and to reinforce adherence. During weeks 1 to 4, weekly home deliveries of groceries will be provided to support early dietary adoption and adherence. During weeks 5-12, participants will receive weekly grocery gift cards to reduce financial barriers and support.
  • Low Potassium Diet — BEHAVIORAL
    The control group (n= 74) will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of \~2000 mg/day. Participants will also be counselled to use cooking techniques (e.g., double-boiling root vegetables) to reduce potassium. Consistent with standard of care, participants will receive monthly education by a registered dietitian using standardized low potassium education materials that contain lists of foods to 'choose' and 'avoid', and individualized to ensure budget, cooking abilities and patient preferences are addressed, as needed. Participants will receive weekly grocery gift cards for 12 weeks.

Study Details

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2030
Completion
Sep 1, 2030

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liberalized Potassium Diet
    The intervention arm will liberalize their potassium intake to include fruits, vegetables, whole grains, nuts and legumes to achieve a daily potassium intake of \~2600-3000 mg per day.
  • Active Comparator: Low Potassium Diet
    The control group will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of \~2000 mg/day.

Primary Outcome Measure

Time-averaged serum potassium [ Time Frame: 12 weeks ]

Central Contacts

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