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| Name | Class |
|---|---|
| University of Manitoba | OTHER |
| Manitoba Egg Farmers | UNKNOWN |
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The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg white protein pudding | Experimental | Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week. |
|
| : Standard dietary supplement | Active Comparator | Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg white protein pudding | Dietary Supplement | Will consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Eligibility to randomization ratio | A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (<0.2) will suggest the trial is not feasible. | Measured at the end of 12 weeks. |
| Recruitment rate | Recruitment rate will be assessed as the number of new participants enrolled per site per month during active recruitment using the red-yellow-green progression criteria. Green: ≥ 0.75 participants/site/month - Feasible; Yellow: 0.25 - <0.75 participants/site/month - Modification may be necessary; Red: < 0.25 participants /site/month - Not feasible | 12 months |
| Follow up rate | Follow-up rate (% of participant outcomes) will be calculated using the red-yellow-green progression criteria. Green: > 90% - Feasible; Yellow: (75% - 90%) -Modifications may be necessary; Red: <75% -Not feasible. | Measured at the end of 12 weeks. |
| Adherence to Intervention | Adherence to egg white product intervention (% of dispensed egg white protein consumed) will be calculated using red-yellow-green progression criteria. Green: > 75% - Feasible; Yellow: 50%-75% - Modifications may be necessary; Red: <50% - Not feasible | Measured at the end of12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip strength | Measuring the amount of static force that the hand can squeeze around a dynamometer. Measured in kilograms and pounds. | Measured at the end of 12 weeks. |
| Change in gait speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Navdeep Tangri, MD, PhD | Contact | 2046313834 | ntangri@sogh.mb.ca | |
| Tahmina Rahman, MSc | Contact | 2046313834 | trahman2@sogh.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Oaks General Hospital | Recruiting | Winnipeg | Manitoba | R2V 3M3 | Canada |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D000073496 | Frailty |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C029401 | Ensure Plus |
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This trial is an open-label randomized controlled parallel arm feasibility trial
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| : Ensure Plus | Dietary Supplement | Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks |
|
Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/__sec)
| Measured at the end of 12 weeks. |
| Five rep chair stand time | the amount of time it takes for a participant to get up out of a chair five times measured in seconds | Measured at the end of 12 weeks. |
| Tandem balance time | Measured in Seconds | Measured at the end of 12 weeks. |
| Serum albumin | Serum albumin is measured in grams per deciliter (g/dL) | Measured at the end of 12 weeks. |
| Serum bicarbonate | Serum bicarbonate concentration in milliequivalents per liter (mEq/L) | Measured at the end of 12 weeks. |
| Calcium | Total blood calcium concentration in mmol/L | Measured at the end of 12 weeks. |
| chloride | Total blood chloride concentration in mmol/L | Measured at the end of 12 weeks. |
| phosphorus | The total blood phosphorus concentration in mmol/L | Measured at the end of 12 weeks. |
| Potassium | The total blood potassium concentration in mmol/L | Measured at the end of 12 weeks. |
| Sodium | The total sodium concentration in mmol/L | Measured at the end of 12 weeks. |
| HbA1c | Total blood glucose concentration in mmol/L | Measured at the end of 12 weeks. |
| Dry Weight | Measured in kg | Measured at the end of 12 weeks |
| Height | Measured in cm | Measured at the end of 12 weeks |
| Pre-dialysis Blood pressure | Systolic and diastolic blood pressure measured in mmHg | Measured at the end of 12 weeks |
| Health Science Centre | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |