UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051960 |
|---|---|
| Receipt number | R000059268 |
| Scientific Title | Food Test |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2023/10/31 15:27:59 |
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Basic information
Public title
A study to evaluate the safety of excessive consumption of the test food in humans.
Acronym
A study to evaluate the safety of excessive consumption of the test food in humans.
Scientific Title
Food Test
Scientific Title:Acronym
Food Test
Region
| Japan |
Condition
Condition
Healthy Subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Four-week excessive intake of test food/open study
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical examination,body weight,BMI,vital signs,clinical examination,Adverse event,Concomitant symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
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
Four-week excessive intake of test food/open study
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,Healthy subjects, males and females, aged 20 or over, and no limit
2,Subjects who have received a sufficient explanation of the purpose and content of the research, have a clear understanding, and voluntarily express their intent to participate, can provide written consent to join the research
Key exclusion criteria
1,Subjects currently undergoing medical treatment or therapy, including medication and traditional herbal medicine, for any form of illness or condition.
2,Subjects undergoing dietary and exercise therapy under the supervision of a doctor
3,Subjects with a current or past history of severe medical conditions.
4,Subjects who regularly consume over-the-counter pharmaceuticals, quasi-drugs, supplements, specific health-use foods, and foods with function claims. (Those who can stop taking them after obtaining consent are eligible to participate.)
5,Subjects with current or past history of medication allergies or food allergies
6,Subjects who have donated blood components or 200ml of whole blood within 1 month from the start of this study
7,Subjects who have donated 400 ml of whole blood within 4 months from the start of this study
8,Subjects who have participated or are currently participating in other clinical trials or clinical research within one month before obtaining consent, or those who plan to participate during the study period
9,Currently pregnant or breastfeeding subjects, or those who are planning to become pregnant during the study period.
10,Subject who regularly drink a lot of alchol (equivalent to 60g/day in terms of alcohol content
11,Subjects with extremely irregular eating habits, shift workers, and subjects with an irregular life rhythm, such as those working night shifts
12,Subjets who are judged by the principal investigator to be unsuitable for participation in this study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Oki |
Organization
Seishukai Clinic
Division name
Director
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
03-5827-0930
t-takahama@seishukai.or.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takahama |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
0358270930
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Seishukai Clinic
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
03-5827-0930
t-takahama@seishukai.or.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 | 08 | Month | 21 | 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 | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059268
