Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

• Sponsor: Puerta de Hierro University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04073693
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.2
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Dietary Supplement: Branched chain amino acids (BRCA)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BRCA They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.	Dietary Supplement: Branched chain amino acids (BRCA); They were with BRCA during the day apart of following the standard recommendations
Placebo Comparator: Placebo They only were on standard treatment based on nutritional intervention and physical exercise.	Dietary Supplement: Branched chain amino acids (BRCA); They were with BRCA during the day apart of following the standard recommendations

Outcome Measures

Primary Outcome Measures

1. Change of muscle mass in patients with sarcopenia [12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jose Luis Calleja	Majadahonda	Madrid	Spain	28222

Sponsors and Collaborators

• Puerta de Hierro University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jose Luis Calleja, Director. Clinical Research, Puerta de Hierro University Hospital
• ClinicalTrials.gov Identifier: NCT04073693
• Other Study ID Numbers: 11.17
• First Posted: Aug 29, 2019
• Last Update Posted: Aug 29, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Liver Cirrhosis; Sarcopenia

Study Results

No Results Posted as of Aug 29, 2019