Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Health Sciences Centre
RECRUITING
Winnipeg
Seven Oaks General Hospital Chronic Disease Innovation Centre
RECRUITING
Winnipeg
Contact Information
Primary
Dylan Mackay, PhD
dylan.mackay@umanitoba.ca
2042723119
Backup
Rebecca Mollard, PhD
rmollard@sogh.mb.ca
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Dalhousie University
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov