UMIN-CTR Clinical Trial

Basic information
Public title	The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Acronym	The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Scientific Title	The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Scientific Title:Acronym	The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Region	Japan

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

Objectives
Narrative objectives1	To verify the inhibitive effect on acute upper respiratory tract inflammation by consumption of test food for 12 continuous weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of upper respiratory tract inflammation symptoms (including influenza) during test period
Key secondary outcomes	1. The days until onset of acute upper respiratory tract inflammation from intervention start 2. The days to recovery from acute upper respiratory tract inflammation 3. The frequency of occurrence of acute upper respiratory tract inflammation symptoms for the term of intervention 4. The occurrence of influenza infection by clinical diagnosis

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	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intervention period: 12 weeks Tea beverage A taken 3 times/day
Interventions/Control_2	Intervention period: 12 weeks Tea beverage B taken 3 times/day
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. male and female ages 20 over 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 caught the flu in the period from 8 months prior to the date of consent up until 24 hours before the start of the study 2. Subjects who had a flu vaccine within eight months prior to the date of consent 3. Subjects who have an allergy to tea (green tea, black tea, oolong tea, barley tea and others) 4. Subjects who have severe disease in digestive organs, heart, lungs, liver, kidneys, respiratory organs 5. Pregnant or expected pregnant, or lactating women 6. Others who have been determined ineligible by investigator 7. Those who do not comply with the test plan
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Shinsaku Middle name Last name Nakagawa
Organization	Osaka University
Division name	Graduate School of Pharmaceutical Sciences
Zip code	565-0871
Address	1-6 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-8175
Email	nakagawa@phs.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shinsaku Middle name Last name Nakagawa
Organization	Osaka University
Division name	Graduate School of Pharmaceutical Sciences
Zip code	565-0871
Address	1-6 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-8175
Homepage URL	http://www.phs.osaka-u.ac.jp/outline/publicity.html
Email	nakagawa@phs.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Pharmaceutical Sciences, Osaka University
Institute
Department

Funding Source
Organization	Mitsui Norin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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 11 Month 08 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	75
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 07 Month 19 Day
Date of IRB	2019 Year 09 Month 13 Day
Anticipated trial start date	2019 Year 11 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 12 Month 12 Day
Last modified on	2022 Year 07 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044317