UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043100 |
|---|---|
| Receipt number | R000049202 |
| Scientific Title | Examination of the immunostimulatory effects of research food intake |
| Date of disclosure of the study information | 2022/04/12 |
| Last modified on | 2021/06/14 20:07:43 |
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Basic information
Public title
Examination of the immunostimulatory effects of research food intake
Acronym
Examination of the immunostimulatory effects of research food intake
Scientific Title
Examination of the immunostimulatory effects of research food intake
Scientific Title:Acronym
Examination of the immunostimulatory effects of research food intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunostimulatory effect of research food intake for 8 consecutive weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
secretory IgA concentration in saliva, secretory IgA flow rate in saliva
Key secondary outcomes
QOL questionnaire, fatigue questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake research food for 8 consecutive weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 64 years of age with lower secretory IgA in saliva.
Key exclusion criteria
(1) Subjects who routinely use health food containing specific ingredients (ex. Resistant dextrin, Polydextrose, Resistant glucan etc. ).
(2) Subjects who constantly use medications affecting the immune system.
(3) Subjects who constantly use supplements and/or functional foods affecting the immune system.
(4) Subjects who intend to get vaccinated within 4 weeks or done.
(5) Subjects who have symptoms that affect the performance of the test.
(6) Subjects who get treatment affecting the test results.
(7) Night and day shift worker or manual laborer
(8) Subjects who habitually do intense exercise such as marathon.
(9) Subjects who cannot carry out inspection procedure as prescribed
(10) Subjects who are judged as having serious diseases
(11) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
(12) Subjects having possibilities for emerging allergy related to the study
(13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(14) Subjects who intend to become pregnant or lactating
(15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(17) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Takagi |
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Division name
RESEARCH INSTITUTE
Zip code
417-8530
Address
30 TAJIMA FUJI, SHIZUOKA
TEL
0545-53-5995
hiroki.takagi@nisshoku.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
yasui475@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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, Meguroku, Tokyo
Tel
03-6452-2712
saito876@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 12 | 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
10
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
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049202
| 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 |
