UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038293 |
|---|---|
| Receipt number | R000043648 |
| Scientific Title | Evaluation of the effect of plant-based food on influenza virus infection: a randomized, placebo-controlled, double-blind, parallel group comparison study. |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2020/06/25 12:57:55 |
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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
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
n2-oka@apoplus.co.jp
Sponsor or person
Institute
Kagome Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043648
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