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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030597
Receipt No. R000034940
Scientific Title Improvement effect of fatty liver and influence of periodontitis by Amazake intake
Date of disclosure of the study information 2017/12/27
Last modified on 2019/06/30

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Basic information
Public title Improvement effect of fatty liver and influence of periodontitis by Amazake intake
Acronym Improvement effect of fatty liver by Amazake
Scientific Title Improvement effect of fatty liver and influence of periodontitis by Amazake intake
Scientific Title:Acronym Improvement effect of fatty liver by Amazake
Region
Japan

Condition
Condition Fatty liver
Classification by specialty
Hepato-biliary-pancreatic medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of improvement of fatty liver and effect on periodontitis by intake of Amazake, a traditional sweet Japanese beverage
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in liver function values and periodontal disease bacteria
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Each patient drinks Amazake (100g, 112 kcal) once a day for 8 weeks.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Fatty liver patients who have liver abnormality such as AST value and ALT value
Key exclusion criteria 1. Patients who consume Amazake for over one month
2. Complicated patients with other liver diseases such as HCV and/or HBV-infected hepatitis
3. Diabetic patients receiving insulin therapy
4. Hepatic encephalopathy, ascites, liver cancer
5. Renal failure
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yumiko
Middle name
Last name Nagao
Organization Saga University
Division name Department of Organ System Interactions and Information, Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
TEL 0952-34-2516
Email nagaoyu@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Yumiko
Middle name
Last name Nagao
Organization Saga University
Division name Department of Organ System Interactions and Information, Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
TEL 0952-34-2516
Homepage URL http://zoukisoukan.med.saga-u.ac.jp
Email nagaoyu@cc.saga-u.ac.jp

Sponsor
Institute Saga University, Department of Organ System Interactions and Information, Faculty of Medicine
Institute
Department

Funding Source
Organization Saga University, scholarship donation
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 Clinical Research Center, Saga University Hospital
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
Tel 0952-34-3400
Email @cc.saga-u.ac.jp

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
2017 Year 12 Month 27 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 10
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
2017 Year 07 Month 03 Day
Date of IRB
2017 Year 04 Month 01 Day
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2019 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034940

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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