An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Impact of added fiber on blood urea nitrogen (BUN)
研究概览
简要总结
A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.
详细描述
Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Participants must:
- •Be 18 years of age or older
- •Have eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis)
排除标准
- •Participants must not:
- •Have been diagnosed with acute kidney injury (AKI)
- •Have been diagnosed with glumerulonephritis (GN)
- •Have been on immunosuppressant/steroid medications
- •Be taking a probiotic supplement and refuse to discontinue it
- •Be scheduled for dialysis within 3 months of study initiation
- •Have a history of liver disease
- •Be on dialysis
- •Have undergone renal transplantation
- •Be breastfeeding
- •Have active gastrointestinal bleeding
- •Have a change in medications over the past 4 weeks
结局指标
主要结局
Impact of added fiber on blood urea nitrogen (BUN)
时间窗: up to 42 days of the study
Blood samples (10 mL) will be taken on day 1, 14, 28, and 42. BUN will be assayed using the Urea Nitrogen Concentrated Reagent method.
次要结局
- Impact of foods with added fiber on Serum Creatinine(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on bowel movement frequency(Daily)
- Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire(Days 1, 14, 28 and 42)
- Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)(Days 1, 14, 28 and 42 of the study)