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临床试验/NCT07772856
NCT07772856尚未招募不适用

Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)

University of Ontario Institute of Technology1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
148
试验地点
1
主要终点
Time-averaged serum potassium

研究概览

简要总结

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.

详细描述

Current potassium guidelines are highly restrictive, limit nutritious whole foods, and contribute to poor diet quality and reduced quality of life - yet largely rely on expert consensus rather than robust trial evidence. To our knowledge, LIBERATE K-HD would be the first RCT to evaluate the safety and sustainability of a liberalized potassium diet in patients receiving hemodialysis, directly addressing this critical evidence gap. By shifting the focus from strict potassium restriction to whole, minimally processed foods, this approach has the potential to simplify dietary advice, improve patient satisfaction, and enhance overall nutrition without increasing the risk of hyperkalemia. The results will directly inform clinical practice guidelines and renal dietetic practice, providing patient-centered evidence to support more flexible and equitabledietary recommendations. The behavioural and adherence data generated will further identify key determinants of sustained dietary change, including food literacy, self-efficacy, and dietary burden, offering guidance for behaviour change counselling and responsible implementation of a liberalized potassium approach in routine dialysis care. If effective, it could support more flexible and patient-centered dietary recommendations that improve both health outcomes and patient well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years on maintenance HD >3 months
  • ≥1 serum potassium concentration >5.0 mmol/L on routine bloodwork in past 12 months
  • Able to provide consent

排除标准

  • Treatment with potassium binders within the preceding 7 days
  • Average Urea reduction rate over the past 3 months <65%
  • >2 missed scheduled dialysis sessions in the previous month
  • Patients receiving <3 hemodialysis sessions per week (ex/ incremental dialysis)
  • Average serum potassium concentration >6.0 mmol/L over the past 3 months
  • Swallowing difficulties or other GI issues preventing adequate intake
  • Residing in an institutional setting (e.g., Long-term care homes) where meals are provided
  • HbA1c >11%
  • Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician

研究组 & 干预措施

Liberalized Potassium Diet

Experimental

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.

干预措施: Liberalized Potassium Diet (Behavioral)

Low Potassium Diet

Active Comparator

The control group will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of ~2000 mg/day.

干预措施: Low Potassium Diet (Behavioral)

结局指标

主要结局

Time-averaged serum potassium

时间窗: 12 weeks

Time-averaged serum potassium is calculated as the mean of all weekly serum potassium measurements (mmol/L) for a participant over the defined study period, providing an integrated measure of potassium exposure over time and reducing the influence of isolated or transient fluctuations. Time-averaged serum potassium will be calculated as the area under the serum potassium-time curve divided by the total observation time.

次要结局

  • Safety - Severe Hyperkalemia(12 weeks)
  • Dietary Nutrient Intake(12 weeks)
  • Health-Related Quality of Life(12 weeks)
  • Diet Quality(12 weeks)
  • Ultra-processed food consumption(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JoAnne Arcand

Associate Professor

University of Ontario Institute of Technology

研究点 (1)

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