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临床试验/NCT02901119
NCT02901119Unknown不适用

Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Nutritional status

研究概览

简要总结

Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or metabolic alterations modify the body composition and biological functions. The purpose of this study is to determine whether whey protein comsumption, due to amino acid profile, digestibility and bioactive compounds may be beneficial for patients waiting for liver transplantation

详细描述

A randomized, double-blind, intervention study in which patients are randomly assigned to receive packages of 20g of whey protein (WP) or casein (CA) to take twice a day (20g in the morning and 20g at night), as a supplement, during 15 days. They are monitored weekly by calls. Regular usual diet is maintained. Patients underwent muscle functionality assessment by handgrip dynamometry and 6-min. walking test and, the inflammatory response by plasmatic cytokines. All tests are performed at the beginning and the end of intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic liver disease, liver transplantation

排除标准

  • •Children, illiterate, elderly, renal failure

研究组 & 干预措施

Casein

Active Comparator

Patients are instructed to consume 20g of casein in the morning and 20g at night, during 15 days, as a supplement. Their regular usual diet is maintained.

干预措施: Whey protein (Dietary Supplement)

Whey protein

Experimental

Patients are instructed to consume 20g of whey protein in the morning and 20g at night, during 15 days, as a supplement. Their regular usual diet is maintained.

干预措施: Whey protein (Dietary Supplement)

结局指标

主要结局

Nutritional status

时间窗: Two years

Anthropometry

次要结局

  • Heart rate variability(Two years)
  • Resting energy expenditure(Two years)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Isabel Toulson Davisson Correia

PhD

Federal University of Minas Gerais

研究点 (1)

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