Unique ID issued by UMIN | UMIN000029849 |
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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 |
The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.
Dietary and functional intervention study.
The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.
Dietary and functional intervention study.
Japan |
fatty liver diseases
Non-alcoholic Fatty Liver Diseases
Non-alcoholic steatohepatitis
Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Exploratory
Pragmatic
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.
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).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Behavior,custom |
Educational intervention
12 months
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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.
26
1st name | |
Middle name | |
Last name | Masashi FURUTA |
National Center for Global Health and Medicine
The Research Center for Hepatitis and Immunology
1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan
047-372-3501
masashi.furuta@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Masashi FURUTA |
National Center for Global Health and Medicine
The Research Center for Hepatitis and Immunology
1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan
047-372-3501
masashi.furuta@med.toho-u.ac.jp
National Center for Global Health and Medicine
The Research Center for Hepatitis and Immunology
Department of Liver Disease
None
Other
NO
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
2017 | Year | 11 | Month | 07 | Day |
Unpublished
Completed
2014 | Year | 05 | Month | 22 | Day |
2014 | Year | 05 | Month | 22 | Day |
2017 | Year | 11 | Month | 06 | Day |
2018 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034018
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