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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051702


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name