UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030597 |
|---|---|
| Receipt number | 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 17:57:33 |
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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
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
nagaoyu@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University, Department of Organ System Interactions and Information, Faculty of Medicine
Institute
Department
Personal name
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
@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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
