Recruiting

Dietary Potassium

Sponsor:

University of Manitoba

Code:

NCT05090865

Conditions

Chronic Kidney Disease

Hyperkalemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liberalized dietary potassium via fruits and vegetables

Standard dietary potassium restriction

Study Details

Brief summary:

The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.

Conditions

Chronic Kidney Disease

Hyperkalemia

Study ID

NCT05090865

Start date

Jan 15, 2024

Status verified date

Jan, 2026

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female, aged 18 years or above
  • Participants who have an 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 ≤ 11%
  • Systolic and diastolic blood pressure \<160/100 mmHg
  • Are registered in the multidisciplinary nephrology clinic in Winnipeg
  • Able to communicate in English and provide written informed consent

Exclusion Criteria:

  • Serum potassium concentration \> 5.6 mEq/L, anuria, dialysis, or acute kidney injury failure in the 6 months prior to screening
  • Chronic obstructive pulmonary disease that requires the participant to be on oxygen
  • New York Heart Association Class 3-4 Heart symptoms or heart, liver or renal transplant
  • A myocardial infarction or stroke within the last 6 months
  • Unable to consume study treatments or control, such as swallowing or gastro-intestinal issues
  • Currently on potassium binding therapy
  • In the opinion of the investigator any medical condition, uncontrolled systemic disease or concurrent illness that would decrease the study compliance or jeopardize the safety of the participant
  • Female participant who is pregnant or lactating

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Liberalized dietary potassium and then restricted potassium via fruit and vegetables

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2-week run-in and liberalized potassium treatment period, then cross-over to the restricted potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional Coronavirus disease (COVID)-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet.

other: Restricted dietary potassium and then liberalized potassium via fruit and vegetables

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2 week run-in and then start receiving a restricted potassium treatment period, then cross-over to the liberalized potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional COVID-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet

Interventions

Liberalized dietary potassium via fruits and vegetables

On the liberalized dietary potassium intervention, participants will receive groceries delivered to their houses that contain potassium rich fruit and vegetables, that contain more than 250 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 2000 mg of potassium a day from delivered fruit and vegetables, and a daily dietary potassium intake of 3500 mg.

Standard dietary potassium restriction

Participants will receive weekly supplementation of lower potassium fruit and vegetables, that deliver less than 200 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 500 mg of K a day from the box, and a daily dietary K intake < 2000 mg. Participants will receive counselling from a registered dietician (RD) to reinforce the potassium restriction.

Primary outcome measure

  • Change in serum potassium concentrations between treatments [ Time Frame: between endpoints of each experimental period (week 8 to week 16) ]

Central Contacts and Locations

Central contacts

Dylan Mackay, PhD

2042723119dylan.mackay@umanitoba.ca

Rebecca Mollard, PhD

rmollard@sogh.mb.ca

Locations

Seven Oaks General Hospital Chronic Disease Innovation Centre

Recruiting

Winnipeg, Manitoba, Canada, R2V 3M3

Contacts

Rebecca Mollard, PhD

rmollard@sogh.mb.ca

Principal Investigator:

Dylan Mackay, PhD

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Jay Hingwala, MD

204-787-3863jhingwala@hsc.mb.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Potassium
  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-01-16.