UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049846 |
|---|---|
| Receipt number | R000056746 |
| Scientific Title | Exploratory study on the relationship between immune parameters and lifestyle habits |
| Date of disclosure of the study information | 2023/03/22 |
| Last modified on | 2023/09/11 09:55:10 |
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Basic information
Public title
Exploratory study on the relationship between immune parameters and lifestyle habits
Acronym
Exploratory study on the relationship between immune parameters and lifestyle habits
Scientific Title
Exploratory study on the relationship between immune parameters and lifestyle habits
Scientific Title:Acronym
Exploratory study on the relationship between immune parameters and lifestyle habits
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A exploratory study will be conducted to investigate the relationship between immune levels and lifestyle habits examining salivary sIgA levels and lifestyle habits on volunteers.
Basic objectives2
Others
Basic objectives -Others
Examine the relationship between immune parameters and lifestyle habits
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between salivary sIgA levels and lifestyle habits data
Relationship between salivary sIgA secretion rate and lifestyle habits data
Key secondary outcomes
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
1.Persons who are 20 years of age or older
2.Persons who have fully understood the purpose and content of this study, and who have voluntarily volunteered and agreed to participate in the study
Key exclusion criteria
None
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Akika |
| Middle name | |
| Last name | Fukawa |
Organization
Meiji Co.,Ltd.
Division name
Food Microbiology and Function Research Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL
042-632-5842
akika.fukawa@meiji.com
Public contact
Name of contact person
| 1st name | Akika |
| Middle name | |
| Last name | Fukawa |
Organization
Meiji Co.,Ltd.
Division name
Food Microbiology and Function Research Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL
042-632-5842
Homepage URL
akika.fukawa@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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee,Kanazawabunko Hospital
Address
2-6-22 Kamariya Higashi, Kanazawa-ku, Yokohama, Kanagawa
Tel
0570-783-706
h.itou@kanabun-hp.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
| 2023 | Year | 03 | 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
553
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 | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct observational studies to investigate immunological parameters and lifestyles in healthy adults.
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056746
