UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of improving on the oral cavity environment with consumption of the functional food
Acronym	A verification study of improving on the oral cavity environment with consumption of the functional food
Scientific Title	A verification study of improving on the oral cavity environment with consumption of the functional food
Scientific Title:Acronym	A verification study of improving on the oral cavity environment with consumption of the functional food
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of functional food on the oral cavity environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	salivary sIgA concentration amount of saliva
Key secondary outcomes	questionnaire about Ease of catching cold, immunity and resistance

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 Other
Interventions/Control_1	Functional food 2 grains/day
Interventions/Control_2	Placebo 2 grains/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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy males and females aged 40-59 years old
Key exclusion criteria	Salmon allergy regularly use excessive alcohol and tobacco extremely irregular diet started to ingest foods for specified health use, foods with functional claims, and other foods and beverages with possible functionalities within the past 4 weeks active in oral care other than brushing teeth (such as mouthwash and frisks) undergoing dental treatment (including orthodontics and whitening) or are scheduled for this exam period willing to become pregnant during pregnancy, breastfeeding, or during the study period diagnosed with some kind of illness and are being treated or taking medication serious illness participated in other clinical trials or plan to participate during this research period persons who will not be judged suitable to the participants by the investigator
Target sample size	40

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	820-0011
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 Koichiro Middle name Last name Ohnuki
Organization	Kindai University
Division name	Faculty of humanity-oriented science and engineering
Zip code	820-0011
Address	11-6, Kayanomori, Iizuka-shi, Fukuoka
TEL	0948-22-5655
Homepage URL
Email	ohnuki@fuk.kindai.ac.jp

Sponsor
Institute	Faculty of humanity-oriented science and engineering ,Kindai University
Institute
Department

Funding Source
Organization	UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Faculty of humanity-oriented science and engineering ,Kindai University
Address	11-6, Kayanomori, Iizuka-shi, Fukuoka
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	2021 Year 09 Month 30 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	No longer recruiting
Date of protocol fixation	2020 Year 08 Month 04 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 07 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047206