UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047547 |
|---|---|
| Receipt number | R000054192 |
| Scientific Title | Safety-confirmation of excessive ingestion of test food |
| Date of disclosure of the study information | 2023/04/27 |
| Last modified on | 2023/08/21 12:54:28 |
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Basic information
Public title
Safety-confirmation of excessive ingestion of test food
Acronym
Safety-confirmation of excessive ingestion of test food
Scientific Title
Safety-confirmation of excessive ingestion of test food
Scientific Title:Acronym
Safety-confirmation of excessive ingestion of test food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to confirm whether the excessive test-food intakes of five times the amount of recommended consumption per day could have sufficient safety.
Basic objectives2
Safety
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 examination 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food (5 packages/day) to the subjects 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy subjects ranging in age from 20 to 64, at the moment of giving informed consent to take part in this research.
(2) Subjects who can give informed consent to participate in this research after being provided with an explanation of our experimental protocol detail.
Key exclusion criteria
(1) Subjects who take steadily in the health-specific/functional/supplementary/health foods, and will have any difficulty in giving up taking them after the consent.
(2) Subjects who have taken some kind of medicine, and have any difficulty in refraining from taking them during this research.
(3) Subjects with excessive alcohol intake.
(4) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(5) Pregnant, possibly pregnant women during this research, or lactating ones.
(6) Subjects with drug and/or food allergy.
(7) Subjects who are now under other clinical researches with some kind of medicine/food, or participated in those within four weeks before this research, or planning to join those after the consent.
(8) Subjects who donated over 200 mL of their blood and/or blood components within a month to this research.
(9) Males who donated their whole blood (400 mL) within the last three months to this research.
(10) Females who donated their whole blood (400 mL) within the last four months to this research.
(11) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research.
(12) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research.
(13) Others who have been determined as ineligible for participation in this research, according to the principal/sub investigator's opinions.
Target sample size
15
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
TSUJIKO 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
| 2023 | Year | 04 | Month | 27 | 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
15
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
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054192
