UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effect of plant-based food on influenza virus infection: a randomized, placebo-controlled, double-blind, parallel group comparison study.
Acronym	Evaluation of the effect of plant-based food on influenza virus infection: a randomized, placebo-controlled, double-blind, parallel group comparison study.
Scientific Title	Evaluation of the effect of plant-based food on influenza virus infection: a randomized, placebo-controlled, double-blind, parallel group comparison study.
Scientific Title:Acronym	Evaluation of the effect of plant-based food on influenza virus infection: a randomized, placebo-controlled, double-blind, parallel group comparison study.
Region	Japan

Condition
Condition	Influenza virus
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of plant-based food ingestion against influenza virus infection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of influenza. Fever (over 37.5) frequency. Fever period.
Key secondary outcomes	Symptoms (headache, pharyngeal pain, cough, abdominal pain)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	Subjects have one test food once a day for 12 weeks.
Interventions/Control_2	Subjects have one test food without effective ingredients once 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)Subjects aged 20 to 59 years old. 2)Subjects without continuous medical treatment. 3)Subjects aware of having cold symptoms at least once a year. 4)Subjects giving written informed consent.
Key exclusion criteria	1) Subjects with severe liver disorders, kidney / cardiac diseases, organ disorders, diabetes, food allergies, digestive disorders, and other serious diseases (including anamnesis). 2) Subjects having food similar to test food more than three times a week. 3)smokers. 4)Subjects with asbestos exposure history (such as coal mine workers). 5)Subjects with severe hay fever. 6) Pregnant women and/or lactating women, and women planning to do so during study period. 7) Alcoholics. 8) Subjects regularly using medicines, foods or supplements for specified health use. 9) Subjects with allergic reaction to test food. 10) Subjects unable to take the test food as directed. 11) Subjects attending other tests. 12)Subjects suffering from influenza between September 1st, 2019 and the date of consent. 13)Subjects working as medical professionals.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Suzuki
Organization	Kagome Co.. Ltd.
Division name	Innovation division
Zip code	329-2762
Address	17, Nishitomiyama, Nasushiobara, Tochigi Prefecture.
TEL	0287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Natsumi Middle name Last name Oka
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Zip code	103-0027
Address	2-14-1, Nihonbashi, Chuo-ku, Tokyo,Japan
TEL	03-6386-8809
Homepage URL
Email	n2-oka@apoplus.co.jp

Sponsor
Institute	Kagome Co.,Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board,Ageo Central Second Hospital
Address	Saitama prefecture Ageo city large character ground side 421-1
Tel	048-781-1101
Email	gairaichiken@ach2.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	2019 Year 10 Month 15 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 27 Day
Date of IRB	2019 Year 10 Month 10 Day
Anticipated trial start date	2019 Year 10 Month 15 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

Other
Other related information

Management information
Registered date	2019 Year 10 Month 15 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043648