UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on the relationship between immunological parameters and lifestyles.
Acronym	Exploratory study on the relationship between immunological parameters and lifestyles.
Scientific Title	Exploratory study on the relationship between immunological parameters and lifestyles.
Scientific Title:Acronym	Exploratory study on the relationship between immunological parameters and lifestyles.
Region	Japan

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

Objectives
Narrative objectives1	We will conduct observational studies to investigate immunological parameters and lifestyles in healthy adults.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between salivary secretory immunoglobulin A (sIgA) concentrations and lifestyles. Relationship between salivary secretory immunoglobulin A (sIgA) secretion rates and lifestyles.
Key secondary outcomes	Relationship between salivary secretory immunoglobulin A concentrations and Natural Killer (NK) cell activities. Relationship between salivary secretory immunoglobulin A (sIgA) secretion rates and Natural Killer (NK) cell activities. Relationship between Natural Killer (NK) cell activities and lifestyles.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	We will recruit participants who meet the following criteria and gave written consent, 1) imformed of the purpose of the study, experimental procedures, and potential risks 2) employee of Meiji Co., Ltd 3) more than 20 years old
Key exclusion criteria	None
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Minoru Middle name Last name Fujita
Organization	Meiji Co., Ltd.
Division name	Marketing Solution Dept, Academic Team
Zip code	104-8306
Address	2-2-1, kyoubashi, Chuo-ku, Tokyo 104-8306, Japan
TEL	03-3273-0865
Email	minoru.fujita@meiji.com

Public contact
Name of contact person	1st name Minoru Middle name Last name Fujita
Organization	Meiji Co., Ltd.
Division name	Marketing Solution Dept, Academic Team
Zip code	104-8306
Address	2-2-1, kyoubashi, Chuo-ku, Tokyo 104-8306, Japan
TEL	03-3273-0865
Homepage URL
Email	minoru.fujita@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
Tel	042-632-5900
Email	MEIJI.IRB@meiji.com

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	株式会社 明治（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 15 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	Completed
Date of protocol fixation	2022 Year 01 Month 21 Day
Date of IRB	2022 Year 01 Month 13 Day
Anticipated trial start date	2022 Year 02 Month 28 Day
Last follow-up date	2022 Year 05 Month 20 Day
Date of closure to data entry	2022 Year 05 Month 26 Day
Date trial data considered complete	2022 Year 06 Month 06 Day
Date analysis concluded	2022 Year 09 Month 26 Day

Other
Other related information	We will conduct observational studies to investigate immunological parameters and lifestyles in healthy adults.

Management information
Registered date	2022 Year 02 Month 14 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053517