UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053926 |
|---|---|
| Receipt number | R000060775 |
| Scientific Title | Examination of the efficacy of Shiitake continuous administration on the immune responses -A exploratory randomized parallel-group trial- |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2024/03/21 14:51:51 |
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Basic information
Public title
Examination of the efficacy of Shiitake continuous administration on the immune responses
Acronym
The continuous administration exploratory randomized parallel-group trial of Shiitake
Scientific Title
Examination of the efficacy of Shiitake continuous administration on the immune responses -A exploratory randomized parallel-group trial-
Scientific Title:Acronym
The continuous administration exploratory randomized parallel-group trial of Shiitake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of 4 weeks of continuous consumption of shiitake mushrooms on immune function, etc., will be explored and compared with those of the non-intake group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HLA-DR, CD40, CD86 expression levels of conventional DC (cDC), plasmacytoid DC (pDC) and monocytes (Multi-color flow cytometry analysis)
Key secondary outcomes
1. Physical condition (common cold-like symptoms)
2. body temperature
3. Mood profile (POMS2 short version)
4. Salivary IgA
5. NK cell activity
6. Adverse events
7. Multicolor flow cytometry analysis of immune cells in peripheral blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Shiitake
Interventions/Control_2
None
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 18 and 64 years old at the time of consent.
2. Subjects who have had common cold-like symptoms with one or more episodes of fever at least one year prior to obtaining consent.
3. Subjects who have been properly informed about the participation in this study, and who have given written consent of their own free will with full understanding.
Key exclusion criteria
1.Subjects who are currently undergoing hospitalization or drug treatment for any disease.
2. Subjects with a history of shiitake mushroom dermatitis.
3. Subjects who cannot consume dried shiitake mushrooms due to taste.
4. Subjects who have a serious systemic disease.
5. Subjects with a history of autoimmune diseases.
6. Subjects who are currently using over-the-counter drugs, quasi-drugs, food for specified health uses, functional foods, supplements, etc. on a regular basis.
7. Subjects who work in shifts.
8. Subjects whose lifestyle (diet, sleep, exercise, etc.) is likely to change significantly during the research period.
9. Pregnant women or those of reproductive potential who are unable to use contraception during the research period.
10. Subjects with food allergies
11. Other subjects deemed inappropriate by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hashimoto |
Organization
University of Tsukuba, Institute of Medicine
Division name
Clinical and translational research methodology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hashimoto |
Organization
University of Tsukuba, Institute of Medicine
Division name
Clinical and translational research methodology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Institute of Medicine
Institute
Department
Personal name
Koichi Hashimoto
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
E-sport Co., Ltd
Ohsyo Shiitake Co., Ltd
National agriculture and food research organization, food research institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Institute of Medicine
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3308
sien.ningenss@un.tsukuba.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
| 2024 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060775
| Research Plan | |
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| 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 |
