UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037325 |
|---|---|
| Receipt number | R000042493 |
| Scientific Title | Effect of continuous intake of onion outer skin powder on human microbiota |
| Date of disclosure of the study information | 2019/08/16 |
| Last modified on | 2020/07/10 09:35:40 |
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Basic information
Public title
Effect of continuous intake of onion outer skin powder on human microbiota
Acronym
onion outer skin powder
Scientific Title
Effect of continuous intake of onion outer skin powder on human microbiota
Scientific Title:Acronym
onion outer skin powder
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of continuous intake of onion outerskin powder on the human intestinal microbiota by molecular microbiological methods
Basic objectives2
Others
Basic objectives -Others
To clarify the the effect of continuous intake of onion outerskin powder on the human intestinal organic acid concentrations
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Significant changes in the composition and counts of intestinal microbiota after intake of onion outer skin powder for 1 week or 2 weeks
Key secondary outcomes
Significant changes in the concentration of intestinal organic acid concentrations
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
To take the onion outer skin powder (4.8g/day) once a day for 14 days
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
no health problems found by the in advance medical check
Key exclusion criteria
health problems are found by the in advance medical check
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nomoto |
Organization
Tokyo University of Agriculture
Division name
Department of Molecular Microbiology
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo
TEL
0354773174
kn206166@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nomoto |
Organization
Tokyo University of Agriculture
Division name
Department of Molecular Microbiology
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo
TEL
0354773174
Homepage URL
kn206166@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
IST Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo
Tel
0354773174
kn206166@nodai.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
東京農業大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 16 | 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
| 2019 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042493
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
