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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002889
Receipt No. 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 2009/12/25

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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
Email

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
Email he-jishu@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
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
2009 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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