UMIN-CTR Clinical Trial

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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