Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

NCT ID: NCT04073693

Last Updated: 2019-08-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-08-09

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BRCA

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

Group Type ACTIVE_COMPARATOR

Branched chain amino acids (BRCA)

Intervention Type DIETARY_SUPPLEMENT

They were with BRCA during the day apart of following the standard recommendations

Placebo

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

Group Type PLACEBO_COMPARATOR

Branched chain amino acids (BRCA)

Intervention Type DIETARY_SUPPLEMENT

They were with BRCA during the day apart of following the standard recommendations

Interventions

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Branched chain amino acids (BRCA)

They were with BRCA during the day apart of following the standard recommendations

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Puerta de Hierro University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jose Luis Calleja

Director. Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jose Luis Calleja

Majadahonda, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 34074812 (View on PubMed)

Other Identifiers

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11.17

Identifier Type: -

Identifier Source: org_study_id

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