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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044259
Receipt No. R000050552
Scientific Title Verification of the effects of foods containing natural products on cold symptoms.
Date of disclosure of the study information 2022/06/20
Last modified on 2021/05/19

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Basic information
Public title Verification of the effects of foods containing natural products on cold symptoms.
Acronym Verification of the effects of foods containing natural products on cold symptoms.
Scientific Title Verification of the effects of foods containing natural products on cold symptoms.
Scientific Title:Acronym Verification of the effects of foods containing natural products on cold symptoms.
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effects of foods containing natural products on cold symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Visual Analogue Scale
Number of days with illness
Key secondary outcomes OSA sleep inventory MA version
Chalder Fatigue Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Foods containing natural products 2 tablets / day
Interventions/Control_2 Placebo Foods 2 tablets / 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

Not applicable
Gender Male and Female
Key inclusion criteria (1) persons who is generally judged
as healthy
(2) Persons who can give voluntary
Written consent to participate
In the present trial
(3) Persons Those who have a feeling of physical and mental fatigue
Key exclusion criteria (1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) persons who have been treated their illness or prevention in a clinic at their informed consent
(5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10)persons who will not be judged suitable to the participants by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Ohnuki
Organization Kindai University
Division name Faculty of humanity-oriented science and engineering
Zip code 820-8555
Address 11-6, Kayanomori, Iizuka-shi, Fukuoka
TEL 0948-22-5655
Email ohnuki@fuk.kindai.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Ohnuki
Organization User Life Science Co., Ltd.
Division name The research and development part
Zip code 820-0115
Address 372-3, Niho, Izuka, Fukuoka, JAPAN
TEL 0948-82-3123
Homepage URL
Email userlifesciense@gmail.com

Sponsor
Institute User Life Science Co., Ltd.
Institute
Department

Funding Source
Organization FS Lab Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Agriculture, Kyushu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kinki University Faculty of Industrial Science and Technology Ethics Committee
Address 11-6 Kayanomori, Iizuka City, Fukuoka Prefecture 820-8555
Tel 0948-22-5655
Email ohnuki@fuk.kindai.ac.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
2022 Year 06 Month 20 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 36
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 No longer recruiting
Date of protocol fixation
2021 Year 05 Month 05 Day
Date of IRB
2021 Year 03 Month 01 Day
Anticipated trial start date
2021 Year 05 Month 20 Day
Last follow-up date
2021 Year 06 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 19 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050552

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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