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Substantially redesigning study protocol and opening a new study in the future.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects in this arm will immediately begin a whole-food, plant-based nutrition program consisting of weekly educational group meetings and prepared meals delivered to the subjects' homes for the first 12 weeks followed by monthly educational group meetings for an additional 6 months. |
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| Wait List Control | Other | Subjects in this arm will continue their usual care as directed by their nephrologist for 12 weeks before starting the same whole-food, plant-based nutrition program as the intervention arm subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole food, plant-based diet | Other | The study diet is whole food, plant based defined as containing no animal products or refined grains or added oils, minimal use of any sweeteners, and, for the purposes of this study, on average containing no more than 15% calories from fat. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic and diastolic blood pressure from baseline | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) | |
| Change in proteinuria from baseline | Urine total protein:creatinine ratio | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Change in GFR from baseline | Serum creatinine (renal function panel) and Cystatin C | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight changes from baseline | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) | |
| BMI changes from baseline | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory stool microbiome evaluation | Changes in microbiome from baseline | 12 weeks (RCT) |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Campbell, MD, MPH | University of Rochester | Principal Investigator |
| Scott E Liebman, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highland Hospital (University of Rochester) | Rochester | New York | 14620 | United States |
Data will be made available for collaboration or other purposes with appropriate data use agreements in place.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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The initial phase of the study will be a three month randomized clinical trial of a whole food plant based nutrition program vs. usual care in patients with chronic kidney disease. Subjects randomized to the intervention arm will start the nutrition program as soon as they are able.
Subjects assigned to the control arm will be placed on a 'wait-list' to start the nutrition program after they undergo three months of testing during their usual care, which consists of routine CKD care as directed by their primary nephrologist. After a 3 month 'wait', they will start the same plant-based nutrition program as the intervention arm subjects.
Both experimental and control group subjects will be followed for a total of 9 months after starting the plant-based dietary intervention. Thus, in addition to the 3-month randomized control trial, there will be data from a 9-month single arm clinical intervention.
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| Waist circumference changes from baseline | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| 8-point bioelectrical impedance analysis changes from baseline | Body composition assessment | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Hemoglobin A1c changes from baseline | Diabetic control | 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| KDQOL-36 changes from baseline | Scoring of this questionnaire consists of 5 scales (symptoms/problem list, effects of kidney disease, burden of kidney disease, SF-12 physical composite, and SF-12 mental composite). The lowest possible score for each scale is 0, indicating the worst outcome, and the best possible score is 100, indicating the best possible outcome. | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Serum potassium changes from baseline | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Serum phosphorus changes from baseline | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Serum albumin changes from baseline | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Blood glucose level changes from baseline | Fasting serum levels from all subjects; additionally, whole blood levels measured by glucometer in subjects with comorbid type 1 or type 2 diabetes mellitus | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Total cholesterol, HDL, LDL, and non-HDL cholesterol level changes from baseline | Fasting lipid panel | 1, 4, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Serum magnesium changes from baseline | 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Parathyroid hormone (PTH) changes from baseline | 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) |
| 25-hydroxycholecalciferol changes from baseline | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Fibroblast growth factor-23 changes from baseline | 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) |
| High sensitivity CRP changes from baseline | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| CBC with differential changes from baseline | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Changes in nutrient intakes from baseline based on 3 day food diaries | Assess baseline compared to intervention diet and assess compliance of intervention diet over study duration | 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects) |
| Changes in urinary indicators of dietary intake from baseline | 24 hour urine collection, urinary oxidation (urinary 8-isoprostane) | 12 weeks (RCT); 3 and 9 months on intervention diet (all subjects) |
| 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 |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |