Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
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
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 29, 2019
CompletedAugust 29, 2019
August 1, 2019
2 years
August 9, 2019
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Study Arms (2)
BRCA
ACTIVE COMPARATORThey were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.
Placebo
PLACEBO COMPARATORThey only were on standard treatment based on nutritional intervention and physical exercise.
Interventions
They were with BRCA during the day apart of following the standard recommendations
Eligibility Criteria
You may qualify if:
- Cirrhotic patients with sarcopenia in abdominal CT.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jose Luis Calleja
Majadahonda, Madrid, 28222, Spain
Related Publications (1)
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.
PMID: 34074812DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director. Clinical Research
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 29, 2019
Study Start
August 1, 2017
Primary Completion
August 1, 2019
Study Completion
August 9, 2019
Last Updated
August 29, 2019
Record last verified: 2019-08