UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001534
Receipt number R000001854
Scientific Title Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Date of disclosure of the study information 2008/11/30
Last modified on 2014/06/09 19:51:32

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Basic information

Public title

Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

Acronym

Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

Scientific Title

Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

Scientific Title:Acronym

Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

Region

Japan


Condition

Condition

esophageal varices

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

1.The rate of improvement in nutritional metabolism using indirect calorimetry
The starting date of study is defined as day0, and endscopic therapies are conducted on day0,day7 and day14. The rate of improvement in non-protein respiratory quotient(npRQ) using indirect calorimetry are evaluated every therapic day.

Key secondary outcomes

1.The rate of improvement by Subjective Global Assessment
The rate of improvements in subjective symptom and physical measurement are evaluated on day0,day7,day14,and day56.
2.The transition of serum protein
The transitional changes of serum albumin, pre-albumin, retinol-binding protein(RBP), branched chain amino acid & tyrosine ratio(BTR) are evaluated on day0,day7,day14,and day56.
3.The changes of glucose tolerance
Glucose tolerance in fasting blood sugar,immunoreactive insulin(IRI) are evaluated on day0,day7,day14,and day56


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients without BCAA before this study.
This group reseives no additional nutrient during whole period of this study.(GroupA)

Interventions/Control_2

Patients without BCAA before this study.
This group reseives two packs of a general liquid nutrient(Racol) per day in two divided breakfast and bedtime during first 14days.Thereafter,no additional nutrient is administered till the end of this study.(GroupB)

Interventions/Control_3

Patients without BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and one pack per day in one divided bedtime next 42days.(GroupC)

Interventions/Control_4

Patients with BCAA before this study.
This group reseives three packs of a BCAA(Livact) per day in two divided breakfast and bedtime during first 14days,and three pack per day in three divided breakfast lunch dinner next 42days.(GroupD)

Interventions/Control_5

Patients with BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and next 42days.(GroupE)

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.patients with esophageal varices who will receive endscopic therapy.
2.patients who understand the study contents and give informed consents by themselves.

Key exclusion criteria

1.patients who took regular administration of albumin products more than once a week for one month.
2.patients with severe disorder of glucose metabolism.
3.patients with severe renal failure.
4.patients with congenital disorder of amino-acid metabolism.
5.patients who are regarded in-eligible by the doctor who participates in this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name shuhei nishiguchi

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine Division of Hepatobiliary and Pancreatc Disease

Zip code


Address

1-1 Mukogawa-cho Nishinomiya

TEL

0798-45-6111

Email

nishiguc@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name yshiyuki sakai

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine Division of Hepatobiliary and Pancreatc Disease

Zip code


Address

1-1 Mukogawa-cho Nishinomiya

TEL

0798-45-6111

Homepage URL


Email

sakai429@hotmail.com


Sponsor or person

Institute

Hyogo College Medicine
Department of internal medicine
Division of Hepatobiliary and Pancreatc Disease

Institute

Department

Personal name



Funding Source

Organization

Hyougo College of Medicine

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

2008 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2008 Year 10 Month 08 Day

Date of IRB


Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 04 Month 01 Day

Date analysis concluded

2013 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 11 Month 30 Day

Last modified on

2014 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name