UMIN-CTR Clinical Trial

Basic information
Public title	Study of protein metabolism and muscle mass improvement by switching to BCAA-enriched nutrient mixture in cirrhotic patients with BCAA granules refractory hypoalbuminemia
Acronym	Protein metabolism and muscle mass improvement in liver cirrhosis patients with BCAA-enriched nutrient mixture
Scientific Title	Study of protein metabolism and muscle mass improvement by switching to BCAA-enriched nutrient mixture in cirrhotic patients with BCAA granules refractory hypoalbuminemia
Scientific Title:Acronym	Protein metabolism and muscle mass improvement in liver cirrhosis patients with BCAA-enriched nutrient mixture
Region	Japan

Condition
Condition	Liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prospectively investigate the effect of nutritional intervention by BCAA-enriched nutrient mixture in BCAA granules formulation refractory cirrhotic patients on hypoalbuminemia, PEM and muscle mass.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of albumin value after 12 weeks
Key secondary outcomes	Muscle mass and body measurement by bioimpedance analysis Evaluation for energy metabolism using indirect calorimetry. Evaluation for protein metabolism Laboratory parameters and physical examinations These will be tested at baseline, 12, 24, 36 and 48 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	BCAA-enriched nutrient mixture group Aminoleban EN, one after eating breakfast and one at sleep for 48 weeks
Interventions/Control_2	BCAA Granules Formulation Group BCAA Granules, after every meal (3 packs/day) for 48 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Cirrhotic patients with hypoalbuminemia (<3.5g/dl) despite taking more than two months of BCAA granules formulation therapy. 2. Patients with hepatic encephalopathy. 3. Patients over 20 years of age. 4. Cirrhotic patients who are expected to take a certain amount of food after nutritional guidance. 5. Previous anti-viral therapies and other nutritional therapies for cirrhosis are not limited. 6. Patients with written informed consent by their free will after full explanation of this trial.
Key exclusion criteria	1.Patients receiving albumin preparations more than once per week 2. Patients who are pointed out to have HCC or those receiving HCC therapy within half a year 3. Patients with poor control of glucose metabolism (HbA1c > 8%) 4. Patients with severe renal dyfunction (serum creatinine > 2.0 or hemodialysis patients) 5. Patients with congenital amino acid metabolism 6. Patients with a history of hypersensitivity to Aminoleban EN 7. Patients with allergies to milk 8. Patients with serious complications 9. Patients who are judged to be ineligible for the study subjects by investigators
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hirayuki Middle name Last name Enomoto
Organization	Hyogo college of medicine
Division name	Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code	6638501
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan
TEL	0798-45-6472
Email	kantan@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Sakai
Organization	Hyogo college of medicine
Division name	Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code	6638187
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan
TEL	0798-45-6472
Homepage URL
Email	kantan@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo college of medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan
Tel	0798-45-6472
Email	kantan@hyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 12 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 12 Day
Last modified on	2019 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040853