UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of food ingredient in healthy adult on the immune system
Acronym	A study to evaluate the effect of food ingredient in healthy adult on the immune system
Scientific Title	A study to evaluate the effect of food ingredient in healthy adult on the immune system
Scientific Title:Acronym	A study to evaluate the effect of food ingredient in healthy adult on the immune system
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

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	65 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 colds (3) Subjects with a low QOL questionnaire score
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 with medicine or food allergy (5) Subjects who have oral or dental problems with bleeding or develops the trouble at least once a week (6) Subjects who are under medication which may influence the outcome of the study (e.g. specific desensitization therapy) (7) Night and day shift worker or manual laborer (8) Subjects who are habitually vigorous exercise such as marathon (include professional athlete) (9) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period (10) Subjects are undergoing medical treatment or judged as require medical treatment (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 who are judged as unsuitable for the study by the principal investigator for other reasons.
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 Mariko Middle name Last name Oe
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	mariko_oe@kewpie.co.jp

Sponsor
Institute	TTC 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	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 25 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	2020 Year 12 Month 10 Day
Date of IRB	2020 Year 12 Month 10 Day
Anticipated trial start date	2020 Year 12 Month 12 Day
Last follow-up date	2021 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 01 Month 08 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049030