Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Serum albumin
研究概览
简要总结
This is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 years old or older
- •diagnosed with stage 5 Chronic Kidney Disease for at least 3 months prior to the starting date of the trial
- •on peritoneal dialysis at least three months prior to the starting date of the trial
- •can provide signed informed consent
- •have no dietary restriction
- •no food allergies
- •no chewing/swallowing difficulties.
排除标准
- •not meeting the above
- •pregnant/lactating as either self-reported or determined by the medical director
- •Chronic Kidney Disease patient stages 1-
- •Chronic Kidney Disease patient undergoing hemodialysis.
- •use of other protein supplement
结局指标
主要结局
Serum albumin
时间窗: up to 6 months of the study
Collection of serum albumin to identify a change from pre-post to analyze the effect protein isolate had on inflammation marker and protein status.
次要结局
- Total protein(up to 6 months of the study)
- normalized protein catabolic rate (nPCR)(up to 6 months of the study)
- mid-arm muscle circumference(up to 6 months of the study)