A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Eligibility to randomization ratio
研究概览
简要总结
The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:
- To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
- To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
- To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.
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
- Single (Outcomes Assessor)
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
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or female aged ≥18 years with CKD
- •On chronic in-center hemodialysis for > 3 months
- •Serum albumin <35 g/L
- •No expected change in dialysis modality or relocation outside of Winnipeg during the intervention period (12 weeks)
排除标准
- •Allergy to eggs
- •History of renal transplant
- •Serum albumin ≥ 35 g/L
- •Bowel diseases
- •Pregnancy
- •Receiving chemotherapy treatment
- •Inability to consume treatment product
- •Allergy to study treatment ingredients
- •Planning on starting an exercise program during the duration of the trial
- •Inability to obtain written informed consent
研究组 & 干预措施
Egg white protein pudding
Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week.
干预措施: Egg white protein pudding (Dietary Supplement)
: Standard dietary supplement
Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week.
干预措施: : Ensure Plus (Dietary Supplement)
结局指标
主要结局
Eligibility to randomization ratio
时间窗: Measured at the end of 12 weeks.
A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (\>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (\<0.2) will suggest the trial is not feasible.
Recruitment rate
时间窗: 12 months
Recruitment rate will be assessed as the number of new participants enrolled per site per month during active recruitment using the red-yellow-green progression criteria. Green: ≥ 0.75 participants/site/month - Feasible; Yellow: 0.25 - \<0.75 participants/site/month - Modification may be necessary; Red: \< 0.25 participants /site/month - Not feasible
Follow up rate
时间窗: Measured at the end of 12 weeks.
Follow-up rate (% of participant outcomes) will be calculated using the red-yellow-green progression criteria. Green: \> 90% - Feasible; Yellow: (75% - 90%) -Modifications may be necessary; Red: \<75% -Not feasible.
Adherence to Intervention
时间窗: Measured at the end of12 weeks
Adherence to egg white product intervention (% of dispensed egg white protein consumed) will be calculated using red-yellow-green progression criteria. Green: \> 75% - Feasible; Yellow: 50%-75% - Modifications may be necessary; Red: \<50% - Not feasible
Eligibility to randomization ratio
时间窗: Measured at the end of 12 weeks.
A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (\>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (\<0.2) will suggest the trial is not feasible.
次要结局
- phosphorus(Measured at the end of 12 weeks.)
- Potassium(Measured at the end of 12 weeks.)
- Sodium(Measured at the end of 12 weeks.)
- HbA1c(Measured at the end of 12 weeks.)
- Dry Weight(Measured at the end of 12 weeks)
- Height(Measured at the end of 12 weeks)
- Pre-dialysis Blood pressure(Measured at the end of 12 weeks)
- Serum albumin(Measured at the end of 12 weeks.)
- Hand grip strength(Measured at the end of 12 weeks.)
- Change in gait speed(Measured at the end of 12 weeks.)
- Five rep chair stand time(Measured at the end of 12 weeks.)
- Tandem balance time(Measured at the end of 12 weeks.)
- Serum bicarbonate(Measured at the end of 12 weeks.)
- Calcium(Measured at the end of 12 weeks.)
- chloride(Measured at the end of 12 weeks.)
- Hand grip strength(Measured at the end of 12 weeks.)
- Change in gait speed(Measured at the end of 12 weeks.)
- Five rep chair stand time(Measured at the end of 12 weeks.)
- Tandem balance time(Measured at the end of 12 weeks.)
- Serum albumin(Measured at the end of 12 weeks.)
- Serum bicarbonate(Measured at the end of 12 weeks.)
- Calcium(Measured at the end of 12 weeks.)
- chloride(Measured at the end of 12 weeks.)
- phosphorus(Measured at the end of 12 weeks.)
- Potassium(Measured at the end of 12 weeks.)
- Sodium(Measured at the end of 12 weeks.)
- HbA1c(Measured at the end of 12 weeks.)
- Dry Weight(Measured at the end of 12 weeks)
- Height(Measured at the end of 12 weeks)
- Pre-dialysis Blood pressure(Measured at the end of 12 weeks)