UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024720 |
|---|---|
| Receipt number | R000028439 |
| Scientific Title | Research about lifestyle and immune function. |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2019/11/07 11:03:06 |
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Basic information
Public title
Research about lifestyle and immune function.
Acronym
Research about lifestyle and immune function.
Scientific Title
Research about lifestyle and immune function.
Scientific Title:Acronym
Research about lifestyle and immune function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the determinants in causing individual differences in immune function and the effect of infections by comparing with people who have strong and weak resistance.
Basic objectives2
Others
Basic objectives -Others
General survey to reveal the correlation among lifestyle, immune function and infection diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey about lifestyle, rate of infection diseases
Key secondary outcomes
Indicators of immune function;
ex) activity of immune cells, deep body temperature, threshold to feel the bitter taste
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese.
Age >=20 and <=59 years.
2) Informed consent provided.
3) Able to follow the instructions of the study team.
Key exclusion criteria
1) Serious disorder
2)Regular hospital visit and medication intended to cure
3)Unable to answer questionnaires containing personal informations
4)women who are or may be pregnant and who are lactating
5)Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyasu Ota |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7828
ota.noriyasu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Kobayashi |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7687
Homepage URL
kobayashi.kaori7@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Address
Tel
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 04 | 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
| 2016 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Regular employee at Kao Corporation as of 4 Nov.2016.
Key inclusion criteria
1) Japanese.
Age >=20 and <=59 years.
2) Informed consent provided.
3) Able to follow the instructions of the study team.
-Questionnaire survey about lifestyle, rate of infection diseases
-Indicators of immune function;
ex) activity of immune cells, deep body temperature, threshold to feel the bitter taste
Management information
Registered date
| 2016 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
