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临床试验/NCT02360748
NCT02360748已完成不适用

A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients

Ochsner Health System4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
4
主要终点
Nutritional Parameters, bone and mineral metabolism

研究概览

简要总结

The study proposes that addition of high protein plant based diet will improve serum albumin as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient will be provided additional food items to help improve their nutritional status.

详细描述

The purpose of this study is to improve the albumin and nutritional status of patient with ESRD on dialysis. Serum albumin is a marker to show how well the patient's overall nutrition is. When albumin level drops it signifies poor outcome in dialysis patients both in terms of complications as well as mortality. Our goal on dialysis is to improve serum albumin level as close to normal as possible. This study intends to also improve phosphorus level by adding high protein sources which are plant based. In this study we intend to add certain plant based food items which are high in protein content. Studies have shown that these particular food items considerably increase serum albumin level but at the same time they are safe as they do not increase the phosphorous levels in kidney patients. Patients will be provided the additional food items and all their nutritional parameters will be monitored at baseline and during the study period of one month

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESRD Patients on dialysis with an albumin of <4.0 with the ability to consent and willingness to enroll in the study

排除标准

  • Other exclusions include
  • liver cirrhosis,
  • cardiac cirrhosis,
  • dysphagia due to an old Cerebrovascular accident / muscular dystrophy,
  • Hyperkalemia (>5.5)

结局指标

主要结局

Nutritional Parameters, bone and mineral metabolism

时间窗: one month

albumin will improve on high protein plant based diet; we will measure patients' baseline nutritional parameters which will include serum album; Calcium and phosphate levels and then follow the same parameters on the dietary intervention

次要结局

  • Phosphorous measurements will be followed during the course of the study and on completion(one month)
  • Obesity(one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naseer Khan, MD

MD

Ochsner Health System

研究点 (4)

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