UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033080 |
|---|---|
| Receipt number | R000037603 |
| Scientific Title | Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake) |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/21 16:02:09 |
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Basic information
Public title
Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Acronym
Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Scientific Title
Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Scientific Title:Acronym
Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We would consider how change our immune related index and lipid related index before and after we consumed Enokitake and other mushrooms as "Foods".
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary secretory IgA levels before and after mushroom ingestion for 1 week.
Key secondary outcomes
Interleukin-4 (IL-4), interleukin-6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-alpha), peripheral blood general test, neutral fat (TG), total cholesterol (TC), HDL, LDL, VLDL, blood fatty acid composition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
Interventions/Control_2
Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
Interventions/Control_3
Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
BMI:18.5-25.0
Physical Activity Level1,2
Key exclusion criteria
1)Invalid person
2)Smoker
3)Person who medicate by immunosuppressant or drug that may affect salivary secretion
4)Person who exercise hard daily
5)Pregnancy, nurse and these preparation
6)Systolic blood pressure under 90mmHg
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawabata Terue |
Organization
Kagawa Nutrition Univercity
Division name
Basic Nutrition Laboratory
Zip code
Address
3-9-21 Chiyoda Sakado-city Saitama Japan
TEL
049-282-3705
enoki-kiso@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hara Yukiko |
Organization
Kagawa Nutrition Univercity
Division name
Basic Nutrition Laboratory
Zip code
Address
3-9-21 Chiyoda Sakado-city Saitama Japan
TEL
049-282-3705
Homepage URL
hya171@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition Univercity
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2018 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037603
| 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 |
