UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study of improvements in the immune activation: an open trial
Title of the study (Brief title)	A verification study of improvements in the immune activation
Region	Japan

Condition
Condition	Healthy Japanese adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of the test beverage on immune activation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Scoring of immunological vigor *Assess at 0 and 4 weeks after consuming
Key secondary outcomes	Immunity test T lymphocyte age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD4+T cells, CD8+T cells, CD8+CD28+T cells, memory T cells *Assess at 0 and 4 weeks after consuming

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test beverage: Kiseisui Dose and direction: Drink 30 mL before the dinner *If you forget to drink the test beverage drink it between after dinner to before going to bed
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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Japanese people who are 40 or more to less than 70 years old with experiencing fatigue 2. Those who are considered as appropriate for the study by the physician 3. Within 2, Priority selection is made in the order of II: warning zone, III: observation zone, and IV: safety zone, in immunological grade at baseline, and V: sufficiently high and I: critical zone are excluded
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Those who are smokers 5. Currently taking medicines and/or herbal medicines 6. Those who are allergic to medicines, milk, beans, orange, and/or other food products 7. Those who are pregnant, breast-feeding, and plan to become a pregnant 8. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 9. Others considered as inappropriate for the study by the physician
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	UTP Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funｄer(s)

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	医療法人社団 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 17 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031365