Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Not Applicable

• Conditions: Liver Cirrhosis

• Registration Number: NCT02407769
• Lead Sponsor: Universidad de Guanajuato

Brief 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)

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 Timeline

• Study Start: 2014-02
• Status Verified: 2015-03
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Posted: 2015-04-03
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

• Hepatorrenal syndrome.
• Hepatopulmonar syndrome
• Diabetes
• Overweight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Composition	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.

Secondary Outcome Measures

Name	Time	Method
Change in Mid arm muscle area	Basal and 30 and 60 days after intervention.	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.
Change in Handgrip strength.	Basal and 30 and 60 days after intervention.	Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force
Change in Quality of life	Basal and 30 and 60 days after intervention.	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)
Change in Fase angle.	Basal and 30 and 60 days after intervention.	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.

Trial Locations

Locations (1)

Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 México, DF, Mexico