UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045264 |
|---|---|
| Receipt number | R000051702 |
| Scientific Title | Preliminary investigation of concerning human immune parameters. |
| Date of disclosure of the study information | 2021/08/28 |
| Last modified on | 2022/08/25 09:47:07 |
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Basic information
Public title
Preliminary investigation of concerning human immune parameters.
Acronym
Preliminary investigation of concerning human immune parameters.
Scientific Title
Preliminary investigation of concerning human immune parameters.
Scientific Title:Acronym
Preliminary investigation of concerning human immune parameters.
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the individual and interindividual differences in several immune indicators.
Basic objectives2
Others
Basic objectives -Others
Examine the individual and interindividual differences in several immune indicators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune cell analysis: expression analysis of cell surface marker in PBMC
Key secondary outcomes
Antibody testing of saliva and serum: antibodies specific to various antigens (microbes and allergens)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Males and females aged more than or equal to 20, and less than 80 when obtaining the consent.
(2)Non-smokers for more than 1 year.
(3)Subjects with a BMI of not less than 18.5 kg/m^2, but less than 35.0 kg/m^2.
(4)Subjects who can comply with the dietary and behavioral restrictions on the day before and the day of the test.
(5)Subjects who can understand the study protocol and agree to participate in the study, by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affect the study results for more than 3 days a week.
(2)Subjects who have a plan or who have taken medication (e.g., antibiotics, steroids, antihistamines), which would affects the study results.
(3)Subjects who take excessive alcohol.
(4)Subjects who are participating or have participated in another clinical study with medicine/food within the last 4 weeks before this study, or are planning to join those after giving informed consent.
(5)Subjects who will be vaccinated with various vaccines during the month leading up to the test-1 and during the test period (e.g., those who are waiting for an appointment or standby for coronavirus vaccination).
(6)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases.
(7)Subjects who are pregnant, lactating, or intend to become pregnant during the study period.
(8)Subjects who are allergic to drugs or foods.
(9-11)Subjects who have been donated their blood components and/or whole blood prior to the pre-inspection as follows:
- males/females: 200 mL of blood components within a month
- males: 400 mL of whole blood within the last 3 months
- females: 400 mL of whole blood within the last 4 months.
(12-13)Subjects who have been donated their blood within the last 12 months, which would reaches to the following volume after adding their blood amount planning to be collected in this study;
- males: 1,200 mL
- females: 800 mL
(14)Subjects with systolic blood pressure of 180 mmHg or higher, and/or diastolic blood pressure of 110 mmHg or higher.
(15) Others who have been determined ineligible by principal/sub investigator.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Neutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga 520-0002, Japan
TEL
+81-775-21-8835
Saito.Hiroshi@otsuka.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
+81-3-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.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
| 2021 | Year | 08 | Month | 28 | 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
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examine the individual and interindividual differences in several immune indicators.
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051702
