UMIN-CTR Clinical Trial

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
Email	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
Email	tomomi_tanaka@kewpie.co.jp

Sponsor
Institute	CPCC Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052330