Effect of a Late Evening Supplementation With Branched Chain Amino Acids on the Nutritional Status in Patients on the Waiting List for Liver Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 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
- 否
入选标准
- •Patients on waiting list for liver transplantation.
- •Diagnosis of undernutrition.
排除标准
- •Hepatorrenal syndrome.
- •Hepatopulmonar syndrome
- •Overweight
研究组 & 干预措施
Branched chain amino acids
The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during the late evening (after 19:00 hours) daily by two months.
干预措施: Late evening supplementation with branched chain amino acids (Dietary Supplement)
Late evening snack
The patients will eat a snack with similar nutrimental facts that food supplement (480 Kcal, 19g of proteins and they were based in casein and vegetable proteins; 17g of lipids and 63g of carbohydrates) during the late evening (after 19:00 hours) daily by two months.
干预措施: Late evening supplementation with branched chain amino acids (Dietary Supplement)
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 Fase angle.(Basal and 30 and 60 days after intervention.)
- 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.)
研究者
Niko Alain Cruz Sancén
Dietitian
Universidad de Guanajuato