NCT02407769

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 17, 2015

Last Update Submit

April 2, 2015

Conditions

Liver Cirrhosis

Keywords

Liver transplantationLiver cirrhosisBranched chain amino acidsLate evening supplementationNutritional status

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • Change in Mid arm muscle area

    Basal and 30 and 60 days after intervention.

  • Change in Quality of life

    Basal and 30 and 60 days after intervention.

  • Change in Fase angle.

    Basal and 30 and 60 days after intervention.

  • Change in Handgrip strength.

    Basal and 30 and 60 days after intervention.

Study Arms (2)

Branched chain amino acids

EXPERIMENTAL

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

Late evening snack

SHAM COMPARATOR

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

Interventions

Late evening supplementation with branched chain amino acidsDIETARY_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.

Also known as: Enterex hepatic
Branched chain amino acidsLate evening snack

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hepatorrenal syndrome.
  • Hepatopulmonar syndrome
  • Diabetes
  • Overweight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Niko Alain Cruz Sancén

    Universidad de Guanajuato

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niko Alain Cruz Sancén

CONTACT

524661043578nick_07a@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 3, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

ME(1)