UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055535 |
|---|---|
| Receipt number | R000062788 |
| Scientific Title | Long-Term Safety Confirmation Trial of a Test Food Product |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2024/09/18 19:18:32 |
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Basic information
Public title
Long-Term Safety Confirmation Trial of a Test Food Product
Acronym
Long-Term Safety Confirmation Trial of a Test Food Product
Scientific Title
Long-Term Safety Confirmation Trial of a Test Food Product
Scientific Title:Acronym
Long-Term Safety Confirmation Trial of a Test Food Product
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of long-term consumption (12 weeks) of the test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events and side effects
Changes in clinical laboratory values
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 capsule a day) for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 20 to below 65 years at the time of consent acquisition.
2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those that may affect sleep, stress, or gut health) three or more times per week and cannot stop consuming them from the time of consent acquisition.
2. Subjects who are taking medications that may affect sleep, stress, or gut health and cannot restrict their use from the time of consent acquisition.
3. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
4. Subjects with excessive alcohol intake.
5. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
6. Females who are pregnant or lactating, and females who could become pregnant during trial period.
7. Subjects with allergies to medications and/or food.
8. Subjects who donated blood or component (200 mL) within the last 1 months.
9. Subjects who donated his blood (400 mL) within the last 3 months.
10. Subjects who donated her blood (400 mL) within the last 4 months.
11. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study.
12. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
13. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | 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
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062788
