UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046903 |
|---|---|
| Receipt number | R000053517 |
| Scientific Title | Exploratory study on the relationship between immunological parameters and lifestyles. |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2022/10/11 14:33:23 |
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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
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
minoru.fujita@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053517
