End Stage Kidney Disease (ESKD)LIBERATE-K HDNCT07772856
Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis
A study testing Liberalized Potassium Diet and Low Potassium Diet in people with End Stage Kidney Disease (ESKD) and Hemodialysis, run by University of Ontario Institute of Technology at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESKD), Hemodialysis, Diet Intervention
- What is being tested?
- Liberalized Potassium Diet and Low Potassium Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Michael's Hospital (Unity Health Toronto)
Toronto, Ontario, M5B1W8
Arti Sharma Parpia, MSc RD, 416-864-5228, Arti.Parpia@unityhealth.to
About this study
Official title: Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)
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.
Read the detailed description
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.
- Conditions
- End Stage Kidney Disease (ESKD), Hemodialysis, Diet Intervention, Hyperkalemia, Potassium Bioavailability
- Being tested
- Liberalized Potassium Diet, Low Potassium Diet
- Keywords
- end stage kidney disease, hemodialysis, diet intervention, hyperkalemia, potassium bioavailability
- Medical subject headings
- Kidney Failure, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberalized Potassium DietBehavioural
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 DietBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Liberalized Potassium Diet |
| 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. Receives: Behavioral: Low Potassium Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-averaged serum potassium
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.
Measured: 12 weeks
Secondary outcomes (5)
Safety - Severe Hyperkalemia
Incidence of clinically meaningful, severe hyperkalemia defined as incident non-hemolyzed serum potassium >6.5 mmol/L at any time point during the study.
Measured: 12 weeks
Dietary Nutrient Intake
Dietary intake will be assessed using the Automated Self-Administered 24-Hour Dietary Recall (ASA24-Canada-2018). The ASA24-C is a self-administered, web-based recall available in English and French (~25 minutes) that incorporates Canadian foods and the Canadian Nutrient File for nutrient analysis. From the ASA24-C, we will calculate mean nutrient intakes, including potassium (mg/day).
Measured: 12 weeks
Health-Related Quality of Life
Health-related quality of life will be assessed using the EQ-5D-5L, a validated, widely used generic indicator of overall health status. It is comprised of five questions assessing the dimension of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: 12 weeks
Diet Quality
From the ASA24-C, diet quality will be assessed using the Healthy Eating Food Index-2019 (HEFI-2019) score (0-80).
Measured: 12 weeks
Ultra-processed food consumption
From the ASA24-C, ultra-processed food (UPF) consumption will be assessed using the NOVA classification system, which categorizes foods according to the degree of industrial processing. It will be calculated as the proportion of total energy intake from ultra-processed foods (% energy from UPF's, NOVA group 4)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ontario Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, JoAnne Arcand, University of Ontario Institute of Technology
- Investigators
- Ron Wald, MD, Principal investigator, Unity Health TorontoJoAnne Arcand, PhD, RD, Principal investigator, University of Ontario Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772856
- Sponsor's protocol ID
- UOntarioIT123
- Other IDs
- 1588293
- Acronym
- LIBERATE-K HD
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)
- ClinicalTrials.gov ID
- NCT07772856
- Acronym / sponsor ID
- LIBERATE-K HD / UOntarioIT123
- Conditions
- End Stage Kidney Disease (ESKD), Hemodialysis, Diet Intervention, Hyperkalemia, Potassium Bioavailability
- Keywords
- end stage kidney disease, hemodialysis, diet intervention, hyperkalemia, potassium bioavailability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of Ontario Institute of TechnologyUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberalized Potassium Diet | Experimental | Behavioral: Liberalized Potassium DietThe 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. |
| Low Potassium Diet | Active comparator | Behavioral: Low Potassium DietThe control group will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of ~2000 mg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberalized Potassium DietFor 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. | Behavioural | Liberalized Potassium Diet |
| Low Potassium DietThe 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. | Behavioural | Low Potassium Diet |
Primary outcome
Time-averaged serum potassium
Time frame: 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.
5 secondary outcomes
Safety - Severe Hyperkalemia
Time frame: 12 weeks
Dietary Nutrient Intake
Time frame: 12 weeks
Health-Related Quality of Life
Time frame: 12 weeks
Diet Quality
Time frame: 12 weeks
Ultra-processed food consumption
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ron Wald, MD principal investigator
Unity Health Toronto
JoAnne Arcand, PhD, RD principal investigator
University of Ontario Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberalized Potassium Diet and Low Potassium Diet in people with End Stage Kidney Disease (ESKD) and Hemodialysis, run by University of Ontario Institute of Technology at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JoAnne Arcand, PhD, RD (905-721-8668 ext. 3796, JoAnne.Arcand@ontariotechu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-averaged serum potassium (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.