Effects of a Whole Food, Plant-Based Nutrition Program on Subjects With Chronic Kidney Disease and Proteinuria
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in systolic and diastolic blood pressure from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Subjects on warfarin
- •Subjects with current eating disorders
- •Subjects with tobacco or illicit substance use
- •Subjects with alcohol use of > 7 drinks per week
- •Allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.)
- •Following a vegan diet in the six months prior to consent
- •Major surgery within 60 days prior to consent
结局指标
主要结局
Change in systolic and diastolic blood pressure from baseline
时间窗: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Change in proteinuria from baseline
时间窗: 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Urine total protein:creatinine ratio
Change in GFR from baseline
时间窗: 1, 4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects)
Serum creatinine (renal function panel) and Cystatin C
次要结局
- Weight changes from baseline(4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects))
- 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(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))
- BMI changes from baseline(4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects))
- Hemoglobin A1c changes from baseline(4, 8, and 12 weeks (RCT); 3, 6, and 9 months on intervention diet (all subjects))
- KDQOL-36 changes from baseline(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(1, 4, 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))
- Changes in nutrient intakes from baseline based on 3 day food diaries(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 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(1, 4, 8, and 12 weeks (RCT); 3, 6, 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))
- Serum magnesium changes from baseline(1, 4, 8, and 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))
- 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))
- Changes in urinary indicators of dietary intake from baseline(12 weeks (RCT); 3 and 9 months on intervention diet (all subjects))
研究者
Erin Campbell
Clinical Assistant Professor
University of Rochester