Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05090865

Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease Trial

Led by University of Manitoba · Updated on 2026-01-16

30

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Manitoba

Lead Sponsor

D

Dalhousie University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how the potassium content in fruits and vegetables affects blood potassium levels in people with Chronic Kidney Disease (CKD). The study aims to provide high-quality evidence to guide dietary potassium recommendations, which currently rely on low-quality data. This research also explores whether a diet higher in potassium from fruits and vegetables might improve quality of life for people with CKD. In this 16-week randomized crossover trial, participants will receive deliveries of fruits and vegetables with either higher or lower potassium content in a random order. Each treatment period lasts 6 weeks, separated by a 2-week washout period. During each period, participants will have a dietary counseling session with a registered dietitian to help incorporate the assigned fruits and vegetables into their regular diet. The potassium-rich foods will aim for about 2000 mg of potassium daily from the delivered produce, while the lower potassium foods will provide less than 500 mg daily. Participants will be monitored throughout the trial with blood and urine tests to measure potassium and other markers, blood pressure checks, and assessments of physical function using a chair stand test. Quality of life related to physical function will also be evaluated. The main outcome is the change in blood potassium levels between the two treatment periods. This study will last about 16 weeks and may influence future dietary advice for people with CKD regarding potassium intake.

CONDITIONS

Brief Title

Dietary Potassium Liberalization in Pre-Dialysis Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Estimated glomerular filtration rate between 15 and 45 ml/min/1.73m2
  • Serum potassium concentration between 4.5 and 5.5 milliequivalent (mEq)/L
  • Hemoglobin A1c less than or equal to 11%
  • Systolic and diastolic blood pressure below 160/100 mmHg
  • Registered in the multidisciplinary nephrology clinic in Winnipeg
  • Able to communicate in English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Serum potassium concentration above 5.6 mEq/L, anuria, dialysis, or acute kidney injury within 6 months before screening
  • Chronic obstructive pulmonary disease requiring oxygen
  • New York Heart Association Class 3-4 heart symptoms or heart, liver, or renal transplant
  • Myocardial infarction or stroke within the last 6 months
  • Unable to consume study treatments due to swallowing or gastrointestinal issues
  • Currently taking potassium binding therapy
  • Any medical condition or uncontrolled disease that reduces study compliance or participant safety
  • Female participants who are pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 2 weeks

Participants receive a 2-week run-in period with liberalized dietary potassium via fruit and vegetables delivered to their homes. A dietary counseling session with a registered dietitian is provided to explain the intervention and recommend preparation methods.

1 counseling session (in-person or videoconference)

Treatment

Duration - 14 weeks

Participants receive 6 weeks of one dietary potassium intervention (either liberalized or restricted potassium fruit and vegetable delivery), followed by a 2-week washout period, then cross over to 6 weeks of the alternate dietary intervention. Each treatment period includes a dietary counseling session with a registered dietitian.

Weekly visits for 14 weeks including grocery deliveries and 2 counseling sessions (in-person or videoconference)

Trial Site Locations

Total: 2 locations

1

Seven Oaks General Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, Canada, R2V 3M3

Actively Recruiting

2

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

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Research Team

D

Dylan Mackay, PhD

R

Rebecca Mollard, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Dietary potassium liberalization with fruit and vegetables versus potassium restriction in people with chronic kidney disease (DK-Lib CKD): a clinical trial protocol.

Yasmin Iman, Robert Balshaw, Mackenzie Alexiuk...

https://pubmed.ncbi.nlm.nih.gov/37833679