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 8 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) Japanese males and females from 20 to 64 years of age (2) Subjects who are aware that they are susceptible to cold (3) Subjects who do not plan to be vaccinated against coronavirus, influenza virus, etc. during the study period (4) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate with a good understanding, and have agreed in writing to participate in the study
Key exclusion criteria	(1)Subjects who regularly intake food containing involvement ingredients at least 3 times a week (2)Subjects suffering from, undergoing treatment for, or with a history of serious diseases (3)Subjects who have chronic diseases and take medication on a daily basis (4)Subjects who regularly use medicines, food for specified health use or functional food, or health food that may affect immunity (5)Subjects who have a habit of taking lactobacillus-rich foods or lactobacillus preparations at least three times a week (6)Subjects who consistently drink more than the appropriate amount of alcohol (7)Subjects who are unable to abstain from alcohol for 2 days prior to screening test and each test (8)Subjects who have food allergies (9)Subjects who are undergoing treatments that may affect the research results (10)Subjects who work day and night shifts or engage in physical labor such as carrying heavy loads (11)Subjects who habitually engage in intense physical activities such as marathon (12)Subjects who fail to follow the prescribed procedures for the various tests during the study (13)Subjects with digestive diseases affecting digestion and absorption and Subjects with a history of digestive surgery (14)Pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding (15)Subjects who are judged to be inappropriate as research subjects based on blood tests (16)Subjects who have a history or current condition of drug or alcohol dependence (17)Subjects who are participating in research involving the ingestion of other foods or the use of other medicines (18)Subjects who plan to travel abroad, including overseas travel, during the study (19)Subjects who has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components (20)Subjects who judges to be inappropriate as research subjects by the principal investigator
Target sample size	60

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	KSO 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	Ethical Committee of Kobuna Orthopedics Clinic
Address	311-2, Gokanmachi, maebashishi, Gunma
Tel	027-261-7600
Email	sagawa@mc-connect.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 10 Month 25 Day
Date of IRB	2021 Year 10 Month 28 Day
Anticipated trial start date	2022 Year 01 Month 15 Day
Last follow-up date	2022 Year 05 Month 06 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 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052331