UMIN-CTR Clinical Trial

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

Chronic liver diseases

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Niigata Liver Metabolism Study Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

06

Month

03

Day

Last modified on

2017

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002447