High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Serum albumin
研究概览
简要总结
The study team aims to provide a food snack that is high in protein (30 g) for two weeks each month (6 treatments per patient per month) for 6 consecutive months, post-dialysis treatment, to in-center hemodialysis patients of all vintages and with all levels and types of comorbidities. The study team will compare changes in serum albumin during the intervention (6 months) using the patients' own serum albumin results that are collected for three months prior to and three months after the intervention. Additionally, the study team will determine participants' dietary habits and appetite pre-, during and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic Hemodialysis (CHD) therapy
- •Active and permanent patients to the area Fresenius Kidney Care (FKC) Dialysis clinic
- •No food allergies or dietary restrictions
- •No contraindications to consuming anything by mouth as per the medical director and/or personal reporting.
排除标准
- •Patients unable to commit to the full time commitments of the study
- •Those who have food allergies, especially to Chicken, Pork Sausage, Eggs, Fresh Cilantro, Red and yellow bell peppers, Cucumbers, Mrs. Dash Grill Seasoning, Newman's Own Ranch Salad Dressing, Minced garlic, Sweet pickle relish, Vidalia onions, tomatoes
- •Dietary restrictions as medically indicated,
- •Trouble chewing/swallowing as confirmed by medical director, and/or personal reporting.
研究组 & 干预措施
Protein Food Snack
Provide a high protein food snack the first 2 weeks of each month for 6 months. Each participant will receive an 8 ounce food snack after dialysis for a total of 6 food snacks for each month.
干预措施: Protein Food Snack (Other)
结局指标
主要结局
Serum albumin
时间窗: Up to 12 months
Change in grams of albumin per deciliter of blood (g/dL). Pre-, during, and 3-months post-intervention will complete monthly serum albumin lab draws.
次要结局
- Serum phosphorus(Up to 12 months)
- Diet Intake(Up to 12 months)