UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045838 |
|---|---|
| Receipt number | R000052330 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2021/11/29 15:08:46 |
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Basic information
Public title
A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym
A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title
A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym
A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method
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 test 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
Immune function
Key secondary outcomes
Physical condition questionnaire
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
Ingestion of test food (research food)
Interventions/Control_2
Ingestion of placebo
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
(1) Healthy males and females from 20 to 64 years of age
(2) Subjects who are aware that they are susceptible to cold and flu
(3) Subjects who have gotten corona virus vaccination twice at least 14 days prior to the date of obtaining consent
(3) Subjects who have received sufficient explanation of this study, understands the contents, and are able to give written consent
Key exclusion criteria
(1) Subjects who regularly intake food containing involvement ingredients at least 3 times a week.
(2) Subjects who constantly use supplements or drugs affecting the immune system.
(3) Subjects who regularly intake food or medicines rich in lactic acid bacteria at least 3 times a week
(4) Subjects who undergoing treatment affecting the outcome of the study
(5) Night and day shift worker or manual laborer
(6) Subjects who are habitually vigorous exercise such as marathon
(7) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period
(8) Subjects are undergoing medical treatment or judged as require medical treatment
(9) Subjects who have under treatment or a history of serious disease
(10) Subjects who are pregnant, lactating, or intending to become pregnant during the study period
(11) Subjects who are allergic to medicines and foods
(12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(13) Subjects who are participating in other clinical trials of drug or health food, or within 4 weeks of completion of the trial, or who plan to participate in other clinical trials after agreeing to participate in the study
(14) Subjects who have donated 200 mL component blood or whole blood for 1 month prior to the study
(15) Men who have donated 400 mL whole blood for 3 months prior to the study
(16) Women who have donated 400 mL of whole blood for 4 months prior to the study
(17) Men who have donated more than 1,200 mL of blood in the 12 months prior to the study, by adding the total planned blood collection volume for the study
(18) Women who have donated more than 800 mL of whole blood in the 12 months prior to the study, by adding the total planned blood volume for the study.
(19) Subjects who are judged as unsuitable for the study by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Tanaka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
tomomi_tanaka@kewpie.co.jp
Sponsor or person
Institute
CPCC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
3-3-5 Uchikannda, Chiyodaku, Tokyo
Tel
03-5297-5548
IRB@cpcc.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
| 2021 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 25 | 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 | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052330
