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临床试验/NCT02407769
NCT02407769Unknown不适用

Effect of a Late Evening Supplementation With Branched Chain Amino Acids on the Nutritional Status in Patients on the Waiting List for Liver Transplantation

Universidad de Guanajuato2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
试验地点
2
主要终点
Change in Body Composition

研究概览

简要总结

Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)

详细描述

Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle < 5.4°, subjective global assessment B or C and/or handgrip strength < 30 in men and < 20 in women). The investigators make them body composition assessment (weight, height, body mass index [BMI], mean arm circumference [MAC], muscle arm area [MAA], tricipital skinfold, Dual X ray absorptiometry [fat mass and fat free mass]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients on waiting list for liver transplantation.
  • Diagnosis of undernutrition.

排除标准

  • Hepatorrenal syndrome.
  • Hepatopulmonar syndrome
  • Overweight

结局指标

主要结局

Change in Body Composition

时间窗: Basal and 30 and 60 days after intervention.

The body composition will be measured with air displacement pletismografy through Bodpod the results will be expressed in percentaje of fat mass and fat free mass.

次要结局

  • Change in Mid arm muscle area(Basal and 30 and 60 days after intervention.)
  • Change in Handgrip strength.(Basal and 30 and 60 days after intervention.)
  • Change in Quality of life(Basal and 30 and 60 days after intervention.)
  • Change in Fase angle.(Basal and 30 and 60 days after intervention.)

研究者

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

Niko Alain Cruz Sancén

Dietitian

Universidad de Guanajuato

研究点 (2)

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