UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of a calorie intake on an energy metabolism in patients with chronic liver diseases
Title of the study (Brief title)	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	Takeshi Suda
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Gastroenterology and Hepatology
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	Tsutomu Kanefuji
Organization	Niigata Liver Metabolism Study Group
Division name	Excuteive office
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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