UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055527 |
|---|---|
| Receipt number | R000063409 |
| Scientific Title | Overdose safety test |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2025/02/21 09:08:47 |
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Basic information
Public title
Overdose safety test
Acronym
Overdose safety test
Scientific Title
Overdose safety test
Scientific Title:Acronym
Overdose safety test
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety of the test food when consumed at three times the recommended daily intake for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression rate of side effects
Key secondary outcomes
[1] Expression rate of adverse events
[2] Results of physical examination, clinical examination (blood test, urinalysis)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of the test food for 4 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Healthy males and females in the age more than 20 and less than 70 years.
[2] Subjects who can submit the written informed consent form.
Key exclusion criteria
[1] Subjects who are on treatment for a serious illness.
[2] Subjects who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction.
[3] Subjects with food allergies or those who may be allergic to the test food.
[4] Subjects who regularly use licensed drugs or quasi-drugs that may affect the study and who are unable to discontinue their intake during the study period.
[5] Subjects who regularly use health foods that may affect the study and who are unable to discontinue their intake during the study period.
[6] Subjects who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test.
[7] Subjects who may be unable to maintain their daily lifestyle.
[8] Subjects who are pregnant or breastfeeding or planning to become pregnant during the study period.
[9] Subjects who participated in other clinical trials within 3 months prior to the date of consent, or plan to participate in other clinical trials during the study period.
[10] Subjects who are judged as ineligible for the study by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Segawa |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu-shi, Saitama, 348-8549, Japan
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Uetake |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Gokammachi, Maebashi-Shi, Gumma, 371-0813, Japan
Tel
027-212-5608
sagawa@mc-connect.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
医療法人 前橋北病院/ Maebashi North Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 18 | 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
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063409
