UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041566 |
|---|---|
| Receipt number | R000047305 |
| Scientific Title | Effects of food intake on liver function and ALT |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2021/10/07 17:24:32 |
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Basic information
Public title
Evaluation of effects of test food intake on liver function and ALT in healthy volunteers
Acronym
Effects of test food intake on liver function and ALT
Scientific Title
Effects of food intake on liver function and ALT
Scientific Title:Acronym
Effects on liver function and ALT
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test foods on serum ALT changes and liver function improvement in healthy individuals with high ALT
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measured ALT value and ALT change amount
Key secondary outcomes
1)Measured AST value
2)Measured GGT value
3)Measured type4collagen7s value
4)Measured Ferritin value
5)Liver disease scoring
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take control food for 12 weeks
Interventions/Control_2
Take test food once a day for 12 weeks
Interventions/Control_3
Take test food twice a day for 12 weeks
Interventions/Control_4
Take test food 4 times a day for 12 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Person who are registered in Shinanokai clinical trial volunteer association
2)Healthy persons aged 45 to under 75
3)Person with serum ALT of 31 to 50 IU/L at observation period 1 and observation period 2 (before ingestion)
4)Person who can obtain written consent from the person
Key exclusion criteria
1)Person who continue to take prescription drugs
2)Person who are on diet or exercise therapy
3)Pregnant women, lactating women and person who have or are willing to become pregnant
4)Person who are unable to comply with the intake management of test foods
5)Person who are allergic to the test food
6)Person who have participated in other clinical trials within the past 3 months
7)Person who have taken Misatol or commercial plum extract within the past 3 months
8)Person who regularly take functional foods related to liver function improvement
9)Others, a person who is judged unfit by the physician in charge of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takazawa |
Organization
Shinanozaka Clinic
Division name
Derector of a clinic
Zip code
160-0017
Address
Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
TEL
0353663006
takazawa@shinanokai.com
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Sasaki |
Organization
Shinanozaka Clinic
Division name
Clinical Trial Department
Zip code
160-0017
Address
Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
TEL
0353663006
Homepage URL
m-sasaki@shinanokai.com
Sponsor or person
Institute
Shinanozaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinanozaka Clinic Ethics Committee
Address
Yotsuya Medical Building 3F, 20 SAmon-cho, Shinjuku-ku
Tel
0353663006
m-iwasaki@shinanokai.com
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
| 2020 | Year | 08 | Month | 26 | 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
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047305
