UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036487 |
|---|---|
| Receipt number | R000040853 |
| 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 |
| Date of disclosure of the study information | 2019/04/12 |
| Last modified on | 2019/10/13 13:19:58 |
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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
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
kantan@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040853
