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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038168
Receipt No. R000043507
Scientific Title A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
Date of disclosure of the study information 2020/10/03
Last modified on 2020/10/09

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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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