Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

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

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)

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Dietary supplement: Late evening supplementation with branched chain amino acids

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • DF
    • México, DF, Mexico, 14000
      • Recruiting
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Contact: Niko Alain Cruz Sancén; Phone Number: 524661043578; Email: nick_07a@hotmail.com
      • Sub-Investigator: Elisa Gómez Reyes
      • Sub-Investigator: Graciela Castro Narro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Hepatorrenal syndrome.
• Hepatopulmonar syndrome
• Diabetes
• Overweight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: Late evening supplementation with 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 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.; Other Names: Enterex hepatic
SHAM_COMPARATOR: 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.	Dietary supplement: Late evening supplementation with 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 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.; Other Names: Enterex hepatic

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad de Guanajuato
• Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Niko Alain Cruz Sancén, Universidad de Guanajuato

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (ESTIMATE): April 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Liver transplantation; Nutritional status; Liver cirrhosis; Branched chain amino acids; Late evening supplementation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: GAS-1103-13/14-1