Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

NCT ID: NCT02407769

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-12-31

Brief Summary

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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

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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).

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Late evening supplementation with branched chain amino acids

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type SHAM_COMPARATOR

Late evening supplementation with branched chain amino acids

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Enterex hepatic

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Hepatorrenal syndrome.
* Hepatopulmonar syndrome
* Diabetes
* Overweight
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role collaborator

Universidad de Guanajuato

OTHER

Sponsor Role lead

Responsible Party

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Niko Alain Cruz Sancén

Dietitian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niko Alain Cruz Sancén

Role: PRINCIPAL_INVESTIGATOR

Universidad de Guanajuato

Locations

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Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Niko Alain Cruz Sancén

Role: CONTACT

524661043578

Facility Contacts

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Niko Alain Cruz Sancén

Role: primary

524661043578

Other Identifiers

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GAS-1103-13/14-1

Identifier Type: -

Identifier Source: org_study_id

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