UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052181 |
|---|---|
| Receipt number | R000059352 |
| Scientific Title | Safety Verification Trial for Test Food Consumption |
| Date of disclosure of the study information | 2024/09/12 |
| Last modified on | 2024/05/20 15:55:11 |
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Basic information
Public title
Safety Verification Trial for Test Food Consumption
Acronym
Safety Verification Trial for Test Food Consumption
Scientific Title
Safety Verification Trial for Test Food Consumption
Scientific Title:Acronym
Safety Verification Trial for Test Food Consumption
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the test food when consumed for 4 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of some kind of adverse event and/or side effect, changes in clinical laboratory values.
Key secondary outcomes
Sleep related items
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
Consumption of the test food (1 bottle a day) for 28 days
Interventions/Control_2
Consumption of the placebo food (1 bottle a day) for 28 days
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. Males and females aged between 20 and 65 at the time of consent.
2. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are consuming Food for specified health use, functional foods, or dietary supplements that affect the autonomic nervous system, metabolism, stress, fatigue, and sleep, and who cannot discontinue their use during the trial period.
2. Subjects being under some kind of continuous medical treatment, including the study period.
3. Subjects who are currently participating in other clinical trials for pharmaceuticals or dietary supplements, or plan to participate in another clinical trial within four weeks after the end of the current trial.
4. Subjects with excessive alcohol intake.
5. Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period.
6. Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one.
7. Subjects who have sensitive skin and skin rash due to rrubber constriction, etc.
8. Subjects with a history or current diagnosis of severe diseases in organs like the heart, liver, kidney, or digestive system.
9. Subjects who are pregnant, nursing, or intend to become pregnant during the trial period.
10. Subjects with allergies to medications or foods.
11. Subjects who donated blood or component (200 mL) within the last 1 months.
12. Subjects who donated his blood (400 mL) within the last 3 months.
13. Subjects who donated her blood (400 mL) within the last 4 months.
14. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research.
15. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research.
16. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
40
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 103-0021, 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 103-0021, 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
Asahi Quality & Innovations, 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 | 12 | 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
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059352
