Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Dietary Supplement: Late evening supplementation with branched chain amino acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on waiting list for liver transplantation. Diagnosis of undernutrition. Exclusion Criteria: Hepatorrenal syndrome. Hepatopulmonar syndrome Diabetes Overweight

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Branched chain amino acids<br>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. | Dietary Supplement: Late evening supplementation with branched chain amino acids<br>* 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 late evening (after 19:00 hours) in comparison with the late evening snack group which will eat a snack based in food with the next nutrimental facts (480 Kcal, 19g of proteins based in casein and vegetables sources, 17g of lipids and 63g of carbohydrates) during the same schedule that intervention group.<br>* Other names: Enterex hepatic;|
| Sham Comparator: Late evening snack<br>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. | Dietary Supplement: Late evening supplementation with branched chain amino acids<br>* 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 late evening (after 19:00 hours) in comparison with the late evening snack group which will eat a snack based in food with the next nutrimental facts (480 Kcal, 19g of proteins based in casein and vegetables sources, 17g of lipids and 63g of carbohydrates) during the same schedule that intervention group.<br>* Other names: Enterex hepatic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | 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. | Basal and 30 and 60 days after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mid arm muscle area | Estimation of muscle area of the no dominant arm using the formula [(MAMA - (π x PT))2 / 4 π ] - 10 in men and -6.5 in women, the result is expressed in cm2. | Basal and 30 and 60 days after intervention. | 
| Change in Quality of life | It will be measured by the questionnaire SF-36 that is a generic scale providing a health profile and is applicable for both, patients and general population; the results that the 36 questions divided in 8 dimensions. The patients answers will be transformed to a numeric scale: since 0 (worst) to 100 (better) | Basal and 30 and 60 days after intervention. | 
| Change in Fase angle. | vectorial sum of the resistance and reactance result in the impedance, and the angle that is formed is called the fase angle; this is obtain through a impedanciometre, the measure is expressed in grades. | Basal and 30 and 60 days after intervention. | 
| Change in Handgrip strength. | Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force | Basal and 30 and 60 days after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Liver cirrhosis, Branched chain amino acids, Late evening supplementation, Nutritional status