UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042680 |
|---|---|
| Receipt number | R000048704 |
| Scientific Title | Preliminary clinical study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in a peripheral blood mononuclear cell and oral mucosal cells. |
| Date of disclosure of the study information | 2020/12/08 |
| Last modified on | 2020/12/07 20:25:15 |
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Basic information
Public title
Preliminary clinical study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in a peripheral blood mononuclear cell and oral mucosa cells.
Acronym
The effect of mushroom extract-containing food on the expression of sirtuins in blood and oral mucosal cells.
Scientific Title
Preliminary clinical study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in a peripheral blood mononuclear cell and oral mucosal cells.
Scientific Title:Acronym
The effect of mushroom extract-containing food on the expression of sirtuins in blood and oral mucosal cells.
Region
| Japan |
Condition
Condition
Healthy donors
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pilot study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in peripheral blood mononuclear cell and oral mucosal cells.
Basic objectives2
Others
Basic objectives -Others
To study the effect of mushroom extract-containing food on the expression of sirtuins.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To study the methods for collection and transportation of samples, and to establish the methods for the analysis of sirtuin levels on blood and oral mucosal cells.
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
Self control
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
mushroom extract containing food
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy donors without allergy of mushroom food
Key exclusion criteria
allergy of mushroom food
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Yudoh |
Organization
St.Marianna University School of Medicine
Division name
Institute of Medical Science
Zip code
2168512
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki City, Japan
TEL
0449778111
yudo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Yudoh |
Organization
St.Marianna University School of Medicine
Division name
Institute of Medical Science
Zip code
2168512
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
TEL
0449778111
Homepage URL
yudo@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University ethics committee in St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
Tel
0449778111
k-sienbu.mail@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 08 | 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
| 2020 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
