- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073693
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
August 27, 2019 updated by: Jose Luis Calleja, Puerta de Hierro University Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Majadahonda, Madrid, Spain, 28222
- Jose Luis Calleja
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BRCA
They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.
|
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.
|
They were with BRCA during the day apart of following the standard recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of muscle mass in patients with sarcopenia
Time Frame: 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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 9, 2019
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
August 29, 2019
Last Update Submitted That Met QC Criteria
August 27, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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