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Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Late evening supplementation with branched chain amino acids
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver transplantation, Liver cirrhosis, Branched chain amino acids, Late evening supplementation, Nutritional status

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Hepatorrenal syndrome.
  • Hepatopulmonar syndrome
  • Diabetes
  • Overweight

Sites / Locations

  • Instituto Nacional de ciencias Médicas y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Branched chain amino acids

Late evening snack

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.
Change in Handgrip strength.
Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force

Full Information

First Posted
March 17, 2015
Last Updated
April 2, 2015
Sponsor
Universidad de Guanajuato
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02407769
Brief Title
Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver transplantation, Liver cirrhosis, Branched chain amino acids, Late evening supplementation, Nutritional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Branched chain amino acids
Arm Type
Experimental
Arm Description
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.
Arm Title
Late evening snack
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Late evening supplementation with branched chain amino acids
Other Intervention Name(s)
Enterex hepatic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Composition
Description
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.
Time Frame
Basal and 30 and 60 days after intervention.
Secondary Outcome Measure Information:
Title
Change in Mid arm muscle area
Description
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.
Time Frame
Basal and 30 and 60 days after intervention.
Title
Change in Quality of life
Description
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)
Time Frame
Basal and 30 and 60 days after intervention.
Title
Change in Fase angle.
Description
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.
Time Frame
Basal and 30 and 60 days after intervention.
Title
Change in Handgrip strength.
Description
Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force
Time Frame
Basal and 30 and 60 days after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients on waiting list for liver transplantation. Diagnosis of undernutrition. Exclusion Criteria: Hepatorrenal syndrome. Hepatopulmonar syndrome Diabetes Overweight
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niko Alain Cruz Sancén
Phone
524661043578
Email
nick_07a@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niko Alain Cruz Sancén
Organizational Affiliation
Universidad de Guanajuato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán
City
México
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niko Alain Cruz Sancén
Phone
524661043578
Email
nick_07a@hotmail.com
First Name & Middle Initial & Last Name & Degree
Elisa Gómez Reyes
First Name & Middle Initial & Last Name & Degree
Graciela Castro Narro

12. IPD Sharing Statement

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Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

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