NCT06343129已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 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
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 high density lipoprotein (HDL) measured in blood(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 % 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 chloride measured in blood(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 parathyroid hormome (PTH) measured in blood(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 burden of kidney disease(Baseline to day 15)
- Mean change in potassium(Baseline to day 15)
- Mean change in symptoms(Baseline to day 15)
- Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite(Baseline to day 15)
- Mean change in total cholesterol measured in blood(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
研究点 (4)
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