UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050352 |
|---|---|
| Receipt number | R000057329 |
| Scientific Title | Study of immune function by the intake of Natto for healthy subjects -A pilot study- |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/02/16 09:03:29 |
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Basic information
Public title
Study of immune function by the intake of Natto for healthy subjects -A pilot study-
Acronym
Study of immune function by the intake of Natto for healthy subjects -A pilot study-
Scientific Title
Study of immune function by the intake of Natto for healthy subjects -A pilot study-
Scientific Title:Acronym
Study of immune function by the intake of Natto for healthy subjects -A pilot study-
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify immune function by the intake of Natto for 4 consecutive weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MFI of pDC activity(HLA-DR, CD86) in the peripheral blood
Key secondary outcomes
MFI of pDC activity(CD-40, CD80) in the peripheral blood
s-IgA in saliva
record of flu-like symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of Natto for 4 consecutive weeks
Interventions/Control_2
Intake of placebo for 4 consecutive weeks
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) Subjects from 18 to 64 years of age
(2) Subjects who agree with the participation in this study after understanding the aim of the study and contents
(3) Subjects who can intake test supplement (Natto or steam soybeans) everyday
(4) Selection of subjects in order of the lower rate of secretion of s-IgA in saliva on preliminary examination
Key exclusion criteria
(1) Subjects who were unaware of influenza, cold symptom, or flu-like symptoms between November in 2020 to November in 2022
(2) Subjects who have caught COVID-19, cold symptom, or flu-like symptoms within the past month prior to the pre-test date
(3) Subjects who are currently taking medication
(4) Subjects who have allergic diseases
(5) Subjects who had vaccination by one month before the pre-test date
(6) Subjects who have the trouble of teeth or oral cavity with bleeding
(7) Subjects who have got treatment teeth or oral cavity within the past month prior to the pre-test date
(8) Subjects who intake food, healthy food or medicine including lactic acid bacterium more than 1 day per week
(9) Subjects who intake Natto 4 days or more per week or intake Natto except test supply during this study
(10) Subjects who are engaged in day / night shift work or midnight work
(11) Subjects who have possibilities for emerging allergy related to the study or a food allergy
(12) Subjects whose total blood collection during this study period will exceed 1200 mL for males and 800 mL for females.
(13) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary
(14) Subjects who have the disease requiring regular medication or a history of serious diseases for which medication was required
(15) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
(16) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(17) Subjects who are participating in the other study at the start of this study
(18) Subjects who plan to become pregnant or breastfeed during the study period
(19) Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Jyoto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamuracho, Handa, Aichi
TEL
080-1576-3917
yoshimoto_jyoutou@mizkan.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Miyayama |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo, 162-0821, Japan
TEL
070-3023-8210
Homepage URL
miyayama.saki392@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd.
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
メディカルステーションクリニック（Medical station clinic）(東京都)、医療法人社団きんせい湯 神楽坂泌尿器科クリニック(Kagurazaka Urology Clinic)(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057329
