UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038168 |
|---|---|
| Receipt number | 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 12:00:21 |
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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
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
ytanaka@mitsui-norin.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043507
