Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407769
• Other study ID #: GAS-1103-13/14-1
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2015
• Last updated: April 2, 2015
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: Universidad de Guanajuato
• Contact: Niko Alain Cruz Sancén
• Phone: 524661043578
• Email: nick_07a[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients on waiting list for liver transplantation.

• Diagnosis of undernutrition.

Exclusion Criteria:

• Hepatorrenal syndrome.

• Hepatopulmonar syndrome

• Diabetes

• Overweight

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán	México	DF

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Guanajuato	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Change in Mid arm muscle area	Estimation of muscle area of the no dominant arm using the formula [(MAMA - (p x PT))2 / 4 p ]; - 10 in men and -6.5 in women, the result is expressed in cm2.	Basal and 30 and 60 days after intervention.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes