Effects of an Education Program Emphasizing a Whole-food, Plant-based Nutrition Program on Blood Pressure and Blood Potassium Levels in Subjects With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Mean change in diastolic blood pressure
研究概览
简要总结
The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.
详细描述
The primary objective of this study is to test the hypothesis that educating hypertensive chronic kidney disease (CKD) stage 3 and 4 patients on the benefit of a whole food plant based (WFPB) diet in the context of a 15-day educational program ("Jumpstart program") will lead to improved blood pressure control and will not increase rates of hyperkalemia.
Other objectives:
A) To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.
B) To test the effect of the Jumpstart program on other important outcomes in CKD in the following domains:
- Body composition such as weight and body mass index (BMI).
- Quality of life.
- Laboratory tests including- serum levels of sodium, bicarbonate, chloride, Blood urea nitrogen, creatinine, calcium, phosphorus, magnesium, albumin, parathyroid hormone, fibroblast growth factor 23, lipids, C-reactive protein and erythrocyte sedimentation rate.
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 3 and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but < 60 ml/min for at least three months)
- •Subjects with hypertension, defined as use of antihypertension medication:
- •Lack of significant proteinuria ( subjects will have a 24 hour urine protein value of < 500 mg or a spot protein to creatinine ratio of < 0.5 or a microalbumin to creatinine ratio < 300) within previous 3 months.
- •Fluent in English language
- •Able and willing to comply with the testing schedule and the meeting schedule of the Jumpstart
- •Able and willing to comply with dietary advice of whole-food plant based diet given during the educational session
- •Able and willing to give informed consent
- •Must have computer/internet access to participate in virtual Zoom educational sessions (intervention group only)
排除标准
- •Kidney disease requiring immunosuppressive therapy
- •Diabetes mellitus
- •Pregnancy
- •Life expectancy < 12 months
- •History of solid organ transplant or anticipated solid organ transplant in next 2 months
- •History of hyperkalemia: (two or more potassium levels ≥ 5.0 Meq/L or those requiring intervention for high potassium levels within the last six months)
- •Subjects with malabsorptive syndromes
- •Subjects with history of bariatric surgery or planned bariatric surgery in the next 2 months
- •Subjects on warfarin
- •Subjects with documented eating disorder at the time of consent
- •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
研究组 & 干预措施
Jumpstart Educational Program
Jumpstart sessions on day 1, 2, 5, 8, 12, and 15. Tests at baseline and week 2 visit: blood pressure, height and weight measurements to calculate a body mass index, urine tests to assess antioxidant activity, quality of life questionnaire (~8 minutes to complete) about physical and mental symptoms, a 3-day food record to assess if participants are changing their diet over the course of the study, assessment of medication use.
Tests performed at day 1, day 8, and day 15: A small blood draw [about 1 teaspoon] to check chemistry levels, cholesterol, and markers of inflammation. Laboratory tests are reviewed once available, and participant contacted by the study team either by telephone or My Chart regarding clinically significant results that require intervention. If potassium levels are higher than 5.2 Meq/L, the study team contacts the participant or their alternate contact directly. For the intervention group, this is in addition to the finger-stick blood collection.
干预措施: Dietary education program (Behavioral)
Control group
Participants randomized to the control group continue to receive medical, dietary, and nutritional advice from their medical team as normal. The testing is the same testing as the intervention group and will be done at day 1, day 8, and day 15 of the study. They do not participate in the educational sessions during the study but will have the opportunity to participate in the program at no charge at the conclusion of the study.
结局指标
主要结局
Mean change in diastolic blood pressure
时间窗: Baseline to day 15
Unit of measurement - mm Hg
Proportion of participants developing hyperkalemia
时间窗: Day 15
Percentage
Mean change in systolic blood pressure
时间窗: Baseline to day 15
Unit of measurement - mm Hg
Mean change in potassium levels
时间窗: Baseline to day 15
Unit of measurement - mEq/L
次要结局
- Mean change in chloride measured in blood(Baseline to day 15)
- Mean change in parathyroid hormome (PTH) measured in blood(Baseline to day 15)
- Mean change in symptoms(Baseline to day 15)
- Mean change in total cholesterol measured in blood(Baseline to day 15)
- Mean change in % calories from fat(Baseline to day 15)
- Mean change in Vegetable protein(Baseline to day 15)
- Mean change in bicarbonate measured in blood(Baseline to day 15)
- Mean change in energy/kg of body mass(Baseline to day 15)
- Mean change in % calories from carbohydrates(Baseline to day 15)
- Mean change in Animal protein(Baseline to day 15)
- Mean change in % calories from protein(Baseline to day 15)
- Mean change in magnesium(Baseline to day 15)
- Mean change in sodium(Baseline to day 15)
- Mean change in body mass(Baseline to day 15)
- Mean change in blood urea nitrogen (BUN) measured(Baseline to day 15)
- Mean change in creatinine measured in blood(Baseline to day 15)
- Mean change in glucose measured in blood(Baseline to day 15)
- Mean change in calcium measured in blood(Baseline to day 15)
- Mean change in phosphorous measured in blood(Baseline to day 15)
- Mean change in erythrocyte sedimentation rate (ESR) measured in blood(Baseline to day 15)
- Mean change in 8-isoprostane measured in urine(Baseline to day 15)
- Mean Change in energy/day(Baseline to day 15)
- Mean change in total fat(Baseline to day 15)
- Mean change in cholesterol(Baseline to day 15)
- Mean change in Total fiber per 1000 kcal(Baseline to day 15)
- Mean change in magnesium measured in blood(Baseline to day 15)
- Mean change in Total dietary fiber(Baseline to day 15)
- Mean change in phosphorous(Baseline to day 15)
- Mean change in low density lipoprotein (LDL) measured in blood(Baseline to day 15)
- Mean change in calcium(Baseline to day 15)
- Mean change in body mass index(Baseline to day 15)
- Mean change in albumin measured in blood(Baseline to day 15)
- Mean change in high density lipoprotein (HDL) measured in blood(Baseline to day 15)
- Mean change in burden of kidney disease(Baseline to day 15)
- Mean change in potassium(Baseline to day 15)
- Mean change in sodium measured in blood(Baseline to day 15)
- Mean change in fibroblast growth factor (FGF)-23 measured in blood(Baseline to day 15)
- Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite(Baseline to day 15)
- Mean change in triglycerides measured in blood(Baseline to day 15)
- Mean change in effects of kidney disease(Baseline to day 15)
- Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite(Baseline to day 15)
研究者
Scott Liebman
Professor of Medicine, Division of Nephrology
University of Rochester