UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054026 |
|---|---|
| Receipt number | R000061623 |
| Scientific Title | Study on the Efficacy of Continuous Intake of Test Food on Liver Function - A Placebo-Controlled Randomized Double-Blind Parallel Group Comparison Trial |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/01 14:56:44 |
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Basic information
Public title
Study on the Efficacy of Continuous Intake of Test Food on Liver Function - A Placebo-Controlled Randomized Double-Blind Parallel Group Comparison Trial
Acronym
Study on the Efficacy of Continuous Intake of Test Food on Liver Function
Scientific Title
Study on the Efficacy of Continuous Intake of Test Food on Liver Function - A Placebo-Controlled Randomized Double-Blind Parallel Group Comparison Trial
Scientific Title:Acronym
Study on the Efficacy of Continuous Intake of Test Food on Liver Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the reduction effect on the blood levels of liver function enzymes and the fat content in the liver, as well as safety, by having men and women aged 20 to 64 take the study food for 24 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood ALT level at 24 weeks of intake
Key secondary outcomes
Blood ALT levels at 6, 12, and 18 weeks of intake
Blood AST levels at 6, 12, 18, and 24 weeks of intake
Blood gamma-GTP levels at 6, 12, 18, and 24 weeks of intake
Liver fat content (FibroScan CAP values) at 12 and 24 weeks of intake
Liver fibrosis-related index at 24 weeks of intake
Fatty liver-related index at 6, 12, 18, and 24 weeks of intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The test food will be consumed once a day for 24 weeks, two tablets each time, after breakfast, without chewing, with water or lukewarm water.
Interventions/Control_2
The placebo food will be consumed once a day for 24 weeks, two tablets each time, after breakfast, without chewing, with water or lukewarm water.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to 64 years old
2. Sex: Japanese men and women, with no restrictions on gender ratio
3. Those with slightly high or borderline ALT levels (20 U/L or more, but less than 51 U/L) at the time of SCR visit
4. Those with BMI less than 30.0 kg/m^2
5. Those who can input electronic diaries via smartphone or PC
6. Those who voluntarily participate after receiving and fully understanding a thorough explanation of the research purpose and content, and who have consented in writing to participate in the study
(SCR2)
7. Those deemed to have no liver metabolic abnormalities or liver function abnormalities requiring treatment
Key exclusion criteria
1. Those with FibroScan VCTE values of 6.0 kPa or more (indicating liver fibrosis).
2. Those currently on medical treatment (except as-needed medication).
3. Those under diet or exercise therapy supervision.
4. Those with a current severe disease.
5. Those regularly utilizing quasi-drugs, drugs, or health foods that may affect test items like obesity, hyperlipidemia, lipid metabolism, and liver function.
6. Those regularly using quasi-drugs, drugs (excluding as-needed medication), and health foods other than item 5 (can participate if able to quit from consent acquisition to trial end).
7. Those with a current or past history of serious liver diseases or suspected of such diseases.
8. Those with gastrointestinal surgery history (except appendicitis).
9. Those with cardiac pacemakers or implanted medical devices.
10. Those with excessive drinking habits (60 g or more for men, 40 g or more for women in pure alcohol conversion per day on a weekly average).
11. Those unable to abstain from alcohol the day before the visit.
12. Those with excessive smoking habits (21 or more cigarettes per day).
13. Those with excessive exercise habits (those aiming for personal best records in competitions).
14. Those with current food or drug allergies.
15. Those with current or past drug or alcohol addiction.
16. Those with night shifts due to shift work.
17. Those planning significant lifestyle changes (diet, sleep, exercise, etc.) during the study period.
18. Those planning to travel overseas during the study period.
19. Those who tested positive for infectious diseases at SCR visit.
20. Those participating in other clinical trials or have participated within one month of the trial end.
21. Those who have had blood drawn more than 200 mL within a month, or more than 400 mL within three months prior to the study period.
22. Pregnant, lactating, or women wishing to become pregnant during the study period.
23. Those deemed unsuitable by the principal investigator, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Division name
Research & Development Headquarters
Zip code
101-0052
Address
Nikko Kanda Bldg. 6F, 1-1 Kanda-Ogawamachi, Chiyoda-ku, Tokyo 101-0052, JAPAN
TEL
03-6632-3516
eno_kaihatsu@otsuka.jp
Public contact
Name of contact person
| 1st name | Yohitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bldg. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
n-yuzawa@imeqrd.co.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
| 2024 | Year | 04 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061623
| Research Plan | |
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| 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 |
