Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria (NCT04171778) | Clinical Trial Compass
TerminatedNot Applicable
Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria
Stopped: Substantially redesigning study protocol and opening a new study in the future.
United States3 participantsStarted 2019-12-05
Plain-language summary
This study will test the hypothesis that lifestyle intervention consisting of a whole food, plant-based (WFPB) diet and group education will favorably impact outcomes germane to individuals with chronic kidney disease (CKD) stage 3b and 4, including blood pressure control, amount of proteinuria (protein in the urine), and preservation of glomerular filtration rate (GFR). In addition, this study will assess weight and body composition, diabetic control in subjects with diabetes as well as CKD, and quality of life. Safety of a WFPB diet in subjects with CKD will be tested with respect to the development of elevated serum potassium and phosphorus, hypoalbuminemia (low blood protein), hypotension (low blood pressure), and hypoglycemia (low blood sugar). An exploratory aim is to test the effects of a WFPB diet on the microbiome of subjects by collecting and analyzing stool samples.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than 18 years
* Subjects with CKD 3b and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but ≤ 45 ml/min for at least three months)
* Subjects with proteinuria documented at least twice with the most recent test within the last 6 months as determined by:
* Urine albumin excretion rate of \> 300 mg/day or urine albumin to creatinine ratio of \> 300 mg/g of creatinine
* Urine protein excretion rate of \> 500 mg/day or urine protein to creatinine ratio of \> 0.5 g/g of creatinine
* If using angiotensin converting enzyme inhibitor, angiotensin receptor blockers and/or aldosterone antagonists, on a stable dose of for greater than one month
* Fluent in English language
* Able and willing to comply with the testing and group education schedules
* Able and willing to comply with a whole-food, plant-based diet
* Able and willing to give informed consent
Exclusion Criteria:
* Any kidney disease requiring immunosuppressive therapy
* Pregnancy or intent to become pregnant in the next 12 months
* Life expectancy \< 12 months
* History of solid organ transplant or anticipated solid organ transplant in next 12 months
* History of hyperkalemia: Two potassium measurements \> 5.1 Meq/L within the last three months, or history of any intervention for hyperkalemia in the last 6 months
* Subjects with malabsorptive syndromes
* Subjects with history of bariatric surgery or planned bariatric surgery in the next 12 months
* Subject…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in systolic and diastolic blood pressure from baseline
Timeframe: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
2
Change in proteinuria from baseline
Timeframe: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
3
Change in GFR from baseline
Timeframe: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)