UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051702