UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041347 |
|---|---|
| Receipt number | R000047206 |
| Scientific Title | A verification study of improving on the oral cavity environment with consumption of the functional food |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2020/08/20 10:56:04 |
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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
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
ohnuki@fuk.kindai.ac.jp
Sponsor or person
Institute
Faculty of humanity-oriented science and engineering ,Kindai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047206
