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Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02407769
Recruitment Status : Unknown
Verified March 2015 by Niko Alain Cruz Sancén, Universidad de Guanajuato.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Niko Alain Cruz Sancén, 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)

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Dietary Supplement: Late evening supplementation with branched chain amino acids Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Enterex hepatic




Primary Outcome Measures :
  1. Change in Body Composition [ Time Frame: 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 :
  1. Change in Mid arm muscle area [ Time Frame: 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.


  2. Change in Quality of life [ Time Frame: 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)

  3. Change in Fase angle. [ Time Frame: 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.

  4. Change in Handgrip strength. [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hepatorrenal syndrome.
  • Hepatopulmonar syndrome
  • Diabetes
  • Overweight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407769


Contacts
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Contact: Niko Alain Cruz Sancén 524661043578 nick_07a@hotmail.com

Locations
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Mexico
Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán Recruiting
México, DF, Mexico, 14000
Contact: Niko Alain Cruz Sancén    524661043578    nick_07a@hotmail.com   
Sub-Investigator: Elisa Gómez Reyes         
Sub-Investigator: Graciela Castro Narro         
Sponsors and Collaborators
Universidad de Guanajuato
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Niko Alain Cruz Sancén Universidad de Guanajuato

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Responsible Party: Niko Alain Cruz Sancén, Dietitian, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT02407769     History of Changes
Other Study ID Numbers: GAS-1103-13/14-1
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015

Keywords provided by Niko Alain Cruz Sancén, Universidad de Guanajuato:
Liver transplantation
Liver cirrhosis
Branched chain amino acids
Late evening supplementation
Nutritional status

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases