UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the immunostimulatory effects of research food intake
Acronym	Examination of the immunostimulatory effects of research food intake
Scientific Title	Examination of the immunostimulatory effects of research food intake
Scientific Title:Acronym	Examination of the immunostimulatory effects of research food intake
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the immunostimulatory effect of research food intake for 8 consecutive weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	secretory IgA concentration in saliva, secretory IgA flow rate in saliva
Key secondary outcomes	QOL questionnaire, fatigue questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake research food for 8 consecutive weeks
Interventions/Control_2
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	Healthy males and females from 20 to 64 years of age with lower secretory IgA in saliva.
Key exclusion criteria	(1) Subjects who routinely use health food containing specific ingredients (ex. Resistant dextrin, Polydextrose, Resistant glucan etc. ). (2) Subjects who constantly use medications affecting the immune system. (3) Subjects who constantly use supplements and/or functional foods affecting the immune system. (4) Subjects who intend to get vaccinated within 4 weeks or done. (5) Subjects who have symptoms that affect the performance of the test. (6) Subjects who get treatment affecting the test results. (7) Night and day shift worker or manual laborer (8) Subjects who habitually do intense exercise such as marathon. (9) Subjects who cannot carry out inspection procedure as prescribed (10) Subjects who are judged as having serious diseases (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 judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Takagi
Organization	NIHON SHOKUHIN KAKO CO., LTD.
Division name	RESEARCH INSTITUTE
Zip code	417-8530
Address	30 TAJIMA FUJI, SHIZUOKA
TEL	0545-53-5995
Email	hiroki.takagi@nisshoku.co.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Yasui
Organization	EP Mediate 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
Email	yasui475@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	NIHON SHOKUHIN KAKO 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
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 12 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	10
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 12 Month 25 Day
Date of IRB	2020 Year 12 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 25 Day
Last follow-up date	2021 Year 04 Month 12 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 22 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049202