UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Demonstration test of the multimodal homeostasis evaluation systems
Title of the study (Brief title)	Demonstration test of the multimodal homeostasis evaluation systems
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the multimodal homeostasis evaluation systems using tangerine juice as a test food.
Basic objectives2	Others
Basic objectives -Others	Evaluate the correlation with existing measurement items and verify the usefulness of this system.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Multimodal homeostasis evaluation systems
Key secondary outcomes	Self-awareness questionnaire, physical examination, antioxidant / anti-inflammatory marker, transcriptome analysis, salivary marker

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	Prevention
Type of intervention	Food
Interventions/Control_1	Tangerine juice 125 ml/day for 4 weeks
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who is 20 years old or more and under 70 years old
Key exclusion criteria	1.Persons who have chronic illness and are receiving medication 2.Persons who are allergic to the test food 3.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 4.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding 5.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size	6

Research contact person
Name of lead principal investigator	Toshihiko Osawa
Organization	Aichi Gakuin University
Division name	Department of Health and Nutrition
Address	12 Araike, Iwasaki-cho, Nisshin-shi, Aichi, Japan
TEL	0561-73-1111
Email	osawat@dpc.aichi-gakuin.ac.jp

Public contact
Name of contact person	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	ishikawa@hc-sys.jp

Sponsor
Institute	Aichi Gakuin University
Institute
Department

Funding Source
Organization	Cabinet Office, Government of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Healthcare Systems Co., Ltd. Control of innate immunity TRA Hamamatsu Photonics K.K.
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 24 Day
Anticipated trial start date	2017 Year 06 Month 12 Day
Last follow-up date	2017 Year 07 Month 11 Day
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 06 Month 01 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031626