UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042600 |
|---|---|
| Receipt number | R000048620 |
| Scientific Title | Examination of the effects of research food intake on immune function. |
| Date of disclosure of the study information | 2022/04/09 |
| Last modified on | 2022/07/07 17:20:55 |
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Basic information
Public title
Examination of the effects of research food intake on immune function.
Acronym
Examination of the effects of research food intake on immune function.
Scientific Title
Examination of the effects of research food intake on immune function.
Scientific Title:Acronym
Examination of the effects of research food intake on immune function.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of research food intake for 12 consecutive weeks on immune function using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition, Immune function
Key secondary outcomes
QOL questionnaire, Stress questionnaire, Blood immune markers, Body temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake research food for 12 consecutive weeks
Interventions/Control_2
Intake placebo for 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 years old and under 65 years old
Key exclusion criteria
(1)Subjects who did not have cold (like) symptoms during Jan, 2019 - Apr, 2020
(2) Subjects who regularly use health food containing involvement ingredients at least 3 times a week.
(3) Subjects who can not restrict drinking the specified beverage during test period.
(4) Subjects who constantly use medications affecting the immune system.
(5)Subjects who constantly use supplements and/or functional foods affecting the immune system.
(6) Subjects who intend to get vaccinated within 4 weeks or done.
(7) Subjects who have symptoms that affect the performance of the test.
(8) Subjects who get treatment affecting the test results.
(9) Night and day shift worker or manual laborer
(10) Subjects who habitually do intense exercise such as marathon.
(11) Subjects who cannot carry out inspection procedure as prescribed
(12) Subjects who are judged as having serious diseases
(13) 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
(14) Subjects having possibilities for emerging allergy related to the study
(15) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(16) Subjects who intend to become pregnant or lactating
(17) 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
(18) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(19) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd.
Division name
Nutrition division
Zip code
510-0844
Address
1-3, Takara-cho, Yokkaichi-shi, Mie
TEL
070-6470-0183
mozeki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
TTC 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
nakagawa768@eps.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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 | 09 | 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
124
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 | 11 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 09 | 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 | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048620
