UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002889 |
|---|---|
| Receipt number | R000003515 |
| Scientific Title | Efficacy of administering at early stage of BCAA supplementation |
| Date of disclosure of the study information | 2009/12/14 |
| Last modified on | 2020/03/31 17:39:54 |
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Basic information
Public title
Efficacy of administering at early stage of BCAA supplementation
Acronym
Efficacy of administering at early stage of BCAA supplementation
Scientific Title
Efficacy of administering at early stage of BCAA supplementation
Scientific Title:Acronym
Efficacy of administering at early stage of BCAA supplementation
Region
| Japan |
Condition
Condition
compensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of administering at the early stage of the BCAA food in the compensatory cirrhosis patient to the glucose intolerance is examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
75g oral glucose tolerance test, HOMA-IR (homeostasis model assessment-insulin resistance) and after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake
Key secondary outcomes
Serum albumin revel, BTR, Zn, platelet, Quality of Life(SF-36) and Urinary 8-OHdG excretion after 12 weeks from the beginning of the dairy BCAA supplementation intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
BCAA supplementation (BCAA3.2g) is taken 12 weeks continuously three times a day.
Interventions/Control_2
Dietary intake of 12 weeks according to usual nourishment guidance
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Compensated cirrhosis
2. Serum albumin revel; 3.5-4.0mg/dL
3. Patients who give documentary informed consent voluntarily
4. Patient who fills all of the above-mentioned 1-3
Key exclusion criteria
1. Decompensated cirrhosis
2. Patient with serious glucose intolerance
3. Patient who has allergy in element of AMINOFEEL
4. Patient who has infectious disease that becomes problem in clinical
5. Patient inappropriate for participating to this study decided by the attending physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nishiguchi |
Organization
Hyogo College of Medicine
Division name
Division of Hepatobiliary and Pancreatic Diseases
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL
0798-45-6472
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Saito |
Organization
Hyogo College of Medicine
Division name
Division of Hepatobiliary and Pancreatic Diseases
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL
0798-45-6472
Homepage URL
he-jishu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 12 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003515
