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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
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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.
The kidney is a primary site of potassium regulation in the body. Hyperkalemia, elevated serum potassium, occurs in approximately 10% of patients with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. To minimize the risk of hyperkalemia, individuals with CKD are told to restrict dietary potassium. This recommendation is based on very-low quality evidence. Dietary potassium restrictions can negatively impact quality of life, and may put participants at risk of nutritional deficiencies so they should be based on good quality evidence. There is a need for high quality randomized controlled trials investigating the impact of dietary potassium modification on serum potassium concentrations in people with CKD.
This trial will evaluate the impact and safety of dietary potassium liberalization using fruit and vegetables on serum potassium concentrations in people with CKD. In this 16-week study, the investigators will test if changing the amount of potassium people with CKD are eating with fruits and vegetables changes the amount of potassium in their blood. The investigators will do this by providing people with fruits and vegetables that are either high or low in potassium for a period of 6 weeks. Then these same participants will be provided with fruits and vegetables that they didn't receive in the first 6 weeks, for an additional 6 weeks in what is called a randomized crossover design. In a randomized crossover design everyone gets both treatments, but the order they get them in is chosen at random, like a coin toss. Thirty participants will be recruited to this study. The investigators will measure blood potassium during the study and see if it changes due to the change in potassium in the fruit and vegetables provided. The investigators think that changing the amount of potassium that participants eat through fruit and vegetables will not lead to a different level of potassium in the participants blood, and that having higher potassium fruit and vegetables in the diet may lead to an increase in the participants quality of life. This study's results could change the dietary recommendation given to people living CKD and potentially allow them to eat a greater variety of food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberalized dietary potassium and then restricted potassium via fruit and vegetables | Other | 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. |
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| Restricted dietary potassium and then liberalized potassium via fruit and vegetables | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberalized dietary potassium via fruits and vegetables | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium concentrations between treatments | Serum potassium at the end of the liberalize dietary potassium period compared to the end of restricted dietary potassium period | between endpoints of each experimental period (week 8 to week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical function related quality of life between treatments | Participants will complete the SF-12 physical component score of the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. | between endpoints of each experimental period (week 8 to week 16) |
| Change in urinary potassium between treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dylan Mackay, PhD | Contact | 2042723119 | dylan.mackay@umanitoba.ca | |
| Rebecca Mollard, PhD | Contact | rmollard@sogh.mb.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dylan Mackay, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Oaks General Hospital Chronic Disease Innovation Centre | Recruiting | Winnipeg | Manitoba | R2V 3M3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37833679 | Derived | Iman Y, Balshaw R, Alexiuk M, Hingwala J, Cahill L, Mollard R, Tangri N, Mackay D. Dietary potassium liberalization with fruit and vegetables versus potassium restriction in people with chronic kidney disease (DK-Lib CKD): a clinical trial protocol. BMC Nephrol. 2023 Oct 13;24(1):301. doi: 10.1186/s12882-023-03354-4. |
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De-identified individual participant data (IPD)may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
Data will become available following the publication of the primary results manuscript.
De-identified IPD may also be requested from the principle investigator upon reasonable request.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Standard dietary potassium restriction | Dietary Supplement | 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. |
|
total potassium concentration in mmol/L |
| between endpoints of each experimental period (week 8 to week 16) |
| Change in urinary sodium between treatments | Total sodium concentration in mmol/L | between endpoints of each experimental period (week 8 to week 16) |
| Urinary albumin to creatinine Ratio | calculated by dividing urinary albumin concentration in milligrams by urinary creatinine concentration in grams | between endpoints of each experimental period (week 8 to week 16) |
| Urinary urea | Measured in mmol/L | between endpoints of each experimental period (week 8 to week 16) |
| Urinary phosphate | Measured in mmol/L | between endpoints of each experimental period (week 8 to week 16) |
| Hemoglobin A1c | Measure of glycosylated hemoglobin, hemoglobin A1c, expressed as a percentage | between endpoints of each experimental period (week 8 to week 16) |
| Systolic blood pressure | Blood pressure will be measured in triplicate using a validated blood pressure monitor following Kidney Disease: Improving Global Outcomes (KDIGO) 2021 measurement guidelines, the average of the 2nd and 3rd measurements will be recorded. | between endpoints of each experimental period (week 8 to week 16) |
| Diastolic blood pressure | Blood pressure will be measured in triplicate using a validated blood pressure monitor following KDIGO 2021 measurement guidelines, the average of the 2nd and 3rd measurements will be recorded. | between endpoints of each experimental period (week 8 to week 16) |
| Five repetition chair stand time | Assessing physical functionality by asking participant to sit with arms folded in a chair and then stand up and sit down 5 times as fast as they can, time to complete is recorded. | between endpoints of each experimental period (week 8 to week 16) |
| Dietary Intake | Dietary intake will be captured via triplicate dietary recall surveys using the Automated Self-Administered 24 hours Canada (ASA24, NCI, Rockville, Maryland, USA; http:// asa24. ca/) | between endpoints of each experimental period (week 8 to week 16) |
| Health Sciences Centre | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |