UMIN-CTR Clinical Trial

Basic information
Public title	A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
Acronym	A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
Scientific Title	A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
Scientific Title:Acronym	A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
Region	Japan

Condition
Condition	Acute upper respiratory tract inflammation
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the inhibition effect for acute upper respiratory tract inflammation by consumption of test food for 12 continuous weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Incidence of upper respiratory tract inflammation during test period *Incidence of influenza infection during test period *Number of onset of upper respiratory tract inflammation during test period *Duration of each upper respiratory tract inflammation during test period *Days from the start of the study to the onset of upper respiratory tract inflammation and influenza
Key secondary outcomes	*Change of sIgA concentration in salivary *Change of NK-cell activity *WURSS-21 Japanese version *Incidence of adverse event and side effect *Body weight *BMI *Physiological tests *Hematological tests *Blood biochemical tests *Urine tests *Feces tests (short chain fatty acid, intestinal microbiota)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	One test food is extracted by 150mL of hot water. Intake the test food extract 3 times a day for 12 weeks.
Interventions/Control_2	One control food is extracted by 150mL of hot water. Intake the control food extract 3 times a day for 12 weeks.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males and Females aged 20 to 59 years old when informed consent. (2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria	(1)Subjects who have infected influenza between 8 months ago from informed consent and 24 hours before test start. (2) Subjects who have injected influenza vaccine within 8 months from informed consent. (3) Subjects who ingesting Food for Specified Health Use (FOSHU), functional indication food and health food on a daily bases. And subjects who will not quit ingesting them during test period. (4) Subjects who have allergy to tea, such as green tea, oolong tea, black tea and/or barley tea. (5) Subjects who have custom of drinking tea more than 2L a day. (6) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (7) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Males who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Suzuki
Organization	Mitsui Norin Co., Ltd.
Division name	R&D group
Zip code	426-0133
Address	223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan
TEL	054-648-2600
Email	masayuks@mitsui-norin.co.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Tanaka
Organization	Mitsui Norin Co., Ltd.
Division name	Fundamental development team, R&D group
Zip code	426-0133
Address	223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan
TEL	054-648-2600
Homepage URL
Email	ytanaka@mitsui-norin.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Mitsui Norin 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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
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	2020 Year 10 Month 03 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	2019 Year 09 Month 24 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 10 Month 03 Day
Last follow-up date	2020 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 01 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043507

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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