UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046972 |
|---|---|
| Receipt number | R000053540 |
| Scientific Title | A single arm study to assess the safety of high dose intake of the test food |
| Date of disclosure of the study information | 2022/05/17 |
| Last modified on | 2023/02/23 10:08:35 |
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Basic information
Public title
A study of safety of high dose intake of the test food
Acronym
A study of safety of high dose intake of the test food
Scientific Title
A single arm study to assess the safety of high dose intake of the test food
Scientific Title:Acronym
A study of safety of high dose intake of the test food
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of high dose intake of the test food in human
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood test
Urinalysis
Physical condition diary
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 18 to less than 75 years old.
2) Subjects who are capable of understanding the study, and those who can give written informed consents.
Key exclusion criteria
1) Subjects who are allergic to products related to the test material of this study.
2) Subjects who are addicted to alcohol or has an extremely irregular dietary habit.
3) Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study.
4) Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period.
5) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Saito |
Organization
Kagawa Nutrition University
Division name
Laboratory of Food Science and Technology
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
TEL
049-282-3729
msaito@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nagata |
Organization
Momoya Co., Ltd.
Division name
Research & Development Division
Zip code
344-8522
Address
410 Akanuma, Kasukabe, Saitama 344-8522, Japan
TEL
048-720-8352
Homepage URL
y.nagata@momoya.co.jp
Sponsor or person
Institute
Momoya Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Momoya Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa Nutrition University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Kagawa Nutrition University
Address
3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
Tel
049-289-6041
kenshien@eiyo.ac.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
女子栄養大学（埼玉県）
Kagawa Nutrition University (Saitama)
株式会社桃屋（埼玉県）
Momoya Co., Ltd. (Saitama)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 17 | 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
10
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 | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 17 | 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 | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053540
