UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029849
Receipt number R000034018
Scientific Title The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.
Date of disclosure of the study information 2017/11/07
Last modified on 2018/11/07 09:41:48

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Basic information

Public title

The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.

Acronym

Dietary and functional intervention study.

Scientific Title

The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.

Scientific Title:Acronym

Dietary and functional intervention study.

Region

Japan


Condition

Condition

fatty liver diseases
Non-alcoholic Fatty Liver Diseases
Non-alcoholic steatohepatitis

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Non-alcoholic fatty liver disease (NAFLD) and a nonalcoholic steatohepatitis (NASH) is required management of diet, and recommended to do a continued exercise. Purpose of this study is to explore the efficacy of the multidisciplinary team approach to support diet therapy accompanying nutritional guidance and exercise instruction accompanying exercise instruction together.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Changes from baseline of skeletal muscle mass; body fat mass; basal metabolism rate; and visceral fat area, at one, two, three, six, nine, and 12 months after the start of the intervention.

Key secondary outcomes

Motor function test (6 minutes walking distance, grip strength,Knee extension muscle strength), blood biochemical test (AST,ALT, GTP, TG,HDL-cho LDL-cho, BS, insulin, iron, ferritin, FFA Hyaluronic acid, type IV collagen 7S, etc.), abdominal supersonic Wave test (liver hardness, rate of change of hepatic fat mass).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Educational intervention

Interventions/Control_2

12 months

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patient diagnosed as fatty liver
2. Patient aged over 20 years old and under 75
3. PS 0 - 1 (ECOG)
4. Patient can intake orally
5. Informed Consent has been obtained in writing form.by himself / herself about examination participation

Key exclusion criteria

1. Patient who has been infected with hepatitis virus
2. Patient has a clear drinking history (Alcohol amount: over 20 g / day)
3. patient who has difficulties in doing exercise, such as any joint pain, kidney dysfunction or heart disease
4. Patient who has poorly controlled diabetes
5. Patient who was judged as inappropriate for this research by physichans.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi FURUTA

Organization

National Center for Global Health and Medicine

Division name

The Research Center for Hepatitis and Immunology

Zip code


Address

1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan

TEL

047-372-3501

Email

masashi.furuta@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi FURUTA

Organization

National Center for Global Health and Medicine

Division name

The Research Center for Hepatitis and Immunology

Zip code


Address

1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan

TEL

047-372-3501

Homepage URL


Email

masashi.furuta@med.toho-u.ac.jp


Sponsor or person

Institute

National Center for Global Health and Medicine
The Research Center for Hepatitis and Immunology
Department of Liver Disease

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

国立国際医療研究センター国府台病院(千葉県)
National Center for Global Health and Medicine Konodai Hospital


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 07 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

2014 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 06 Day

Last modified on

2018 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name