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Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Branched chain amino acids (BRCA)
Sponsored by
Puerta de Hierro University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

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

Inclusion Criteria:

  • Cirrhotic patients with sarcopenia in abdominal CT.

Exclusion Criteria:

  • chronic renal failure or being on hemodialysis
  • active hepatitis B or C virus infection
  • active alcohol abuse
  • coinfection with human immunodeficiency virus
  • renal or previous liver transplantation
  • history of neoplasia requiring chemotherapy or radiotherapy
  • hepatocellular carcinoma outside of Milan criteria
  • TIPs
  • unwillingness to participate in the study.

Sites / Locations

  • Jose Luis Calleja

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BRCA

Placebo

Arm Description

They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.

They only were on standard treatment based on nutritional intervention and physical exercise.

Outcomes

Primary Outcome Measures

Change of muscle mass in patients with sarcopenia
To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia

Secondary Outcome Measures

Full Information

First Posted
August 9, 2019
Last Updated
August 27, 2019
Sponsor
Puerta de Hierro University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04073693
Brief Title
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
Official Title
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRCA
Arm Type
Active Comparator
Arm Description
They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
They only were on standard treatment based on nutritional intervention and physical exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Branched chain amino acids (BRCA)
Intervention Description
They were with BRCA during the day apart of following the standard recommendations
Primary Outcome Measure Information:
Title
Change of muscle mass in patients with sarcopenia
Description
To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cirrhotic patients with sarcopenia in abdominal CT. Exclusion Criteria: chronic renal failure or being on hemodialysis active hepatitis B or C virus infection active alcohol abuse coinfection with human immunodeficiency virus renal or previous liver transplantation history of neoplasia requiring chemotherapy or radiotherapy hepatocellular carcinoma outside of Milan criteria TIPs unwillingness to participate in the study.
Facility Information:
Facility Name
Jose Luis Calleja
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34074812
Citation
Hernandez-Conde M, Llop E, Gomez-Pimpollo L, Fernandez Carrillo C, Rodriguez L, Van Den Brule E, Perello C, Lopez-Gomez M, Abad J, Martinez-Porras JL, Fernandez-Puga N, Ferre C, Trapero M, Fraga E, Calleja JL. Adding Branched-Chain Amino Acids to an Enhanced Standard-of-Care Treatment Improves Muscle Mass of Cirrhotic Patients With Sarcopenia: A Placebo-Controlled Trial. Am J Gastroenterol. 2021 Nov 1;116(11):2241-2249. doi: 10.14309/ajg.0000000000001301.
Results Reference
derived

Learn more about this trial

Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

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