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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002040
Receipt No. R000002447
Scientific Title The effects of a calorie intake on an energy metabolism in patients with chronic liver diseases
Date of disclosure of the study information 2009/07/01
Last modified on 2017/04/01

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Basic information
Public title The effects of a calorie intake on an energy metabolism in patients with chronic liver diseases
Acronym A calorie intake and an energy metabolism in chronic liver diseases
Scientific Title The effects of a calorie intake on an energy metabolism in patients with chronic liver diseases
Scientific Title:Acronym A calorie intake and an energy metabolism in chronic liver diseases
Region
Japan

Condition
Condition Chronic liver diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objects of this study are as follows;
1)whether a reduction of calorie intake after admission leads to a decrease of non-protein respiratory quotient (npRq)
2)whether a maintenance of calorie intake at home prohibits a reduction of npRq after admission
3)whether an administration of branched-chain amino acids before sleep (late evening snack; LES) improves npRq in a group taking a calorie normalized to resting energy expenditure
4)whether thre are significant correlation between nrRq and subclinical hepatic encephalopathy
5)whether LES is effective for subclinical hepatic encephalopathy
6)whether an improvement after treatments for hepatocellular carcinoma depends on npRq
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes 1)non-protein respiratory quotient
2)neuro-psychological test
3homeostasis model assessment of insulin resistance
4)nitrogen balance
5)Branched-chain amino acid/Tyrosine molar ratio
6)hospital days
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Noramal calorie intake at home,
Keep the calorie at home after admission,
No additional branched-chain amino acids
Interventions/Control_2 Noramal calorie intake at home,
Keep the calorie at home after admission,
Additional branched-chain amino acids
Interventions/Control_3 Exceeded calorie intake at home,
Keep the calorie at home after admission,
No additional branched-chain amino acids
Interventions/Control_4 Exceeded calorie intake at home,
Keep the calorie at home after admission,
Additional branched-chain amino acids
Interventions/Control_5 Exceeded calorie intake at home,
Normalize the calorie at home after admission,
No additional branched-chain amino acids
Interventions/Control_6 Exceeded calorie intake at home,
Normalize the calorie at home after admission,
Additional branched-chain amino acids
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)A therapy for hepatocellular carcinomas is conducted under addmission in our hospital
2)Performance States 0-2
3)An informed concent was obtained in a written form from the patient
Key exclusion criteria 1) Calorie intake at home are lower than 80% of standard calorie estimated from Harris-Benedict formula.
2) The concentration of creatinine in the serum was more than 2.0 mg/dl.
3) Allergic reaction was evoked by milk.
4) Hasegawa Dementia Scale revealed an overt dementia
5) Technically it is hard to perform a neuro-psychological test
6) An attending doctor judged inadequate due to any reason


Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Suda
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122
TEL 025-227-2207
Email tspitt@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Kanefuji
Organization Niigata Liver Metabolism Study Group
Division name Excuteive office
Zip code
Address 1-757 Asahi-Machi, Chuo-Ku, Niigata, Niigata 951-8122
TEL 025-227-2207
Homepage URL
Email kanefuji1229@gmail.com

Sponsor
Institute Niigata Liver Metabolism Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 07 Month 01 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 Completed
Date of protocol fixation
2009 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 03 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002447

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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