UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042779 |
|---|---|
| Receipt number | R000048825 |
| Scientific Title | Study of the effect of plant extract on the oral environment |
| Date of disclosure of the study information | 2020/12/17 |
| Last modified on | 2022/12/20 09:20:52 |
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Basic information
Public title
Study of the effect of plant extract on the oral environment
Acronym
Study of improving the oral environment
Scientific Title
Study of the effect of plant extract on the oral environment
Scientific Title:Acronym
Study of improving the oral environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of the effects of plant extract on the oral microbiota and oral environment when ingested continuously for a week by adults aged 35 years old or more and under 69 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral microbiota (16S metagenomic comprehensive analysis)
Number of periodontal disease bacteria (Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium spp., Total number of bacteria)
Key secondary outcomes
Dental plaque
Swelling of the gums (gingivitis index)
Bad breath
Tongue coating
Questionnaire (self-bad breath, sticky feeling, refreshing feeling)
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
Take 280 ml (840 ml total) of the beverage containing plant extract every day after each meal for a week
Interventions/Control_2
Take 280 ml (840 ml total) of the placebo beverage every day after each meal for a week
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
| 35 | years-old | <= |
Age-upper limit
| 69 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 35 years old or more and under 69 years old.
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually drink 1L or more of green tea a day
4.Persons who regularly use medicines, foods for specified health use, health foods, etc. that may affect the oral microbiota
5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6.Persons who were judged as inappropriate for subjects by the principal investigator
7.Persons who are breastfeeding,
pregnant, planning or hoping to become pregnant during the examination period
8.Persons who have removable dentures
9.Persons who are undergoing treatment for dental caries and periodontal disease
10.Persons who usually smoke
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd.
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi City, Mie Prefecture
TEL
059-347-5411
mozeki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd.
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi City, Mie Prefecture
TEL
059-347-5411
Homepage URL
mozeki@taiyokagaku.co.jp
Sponsor or person
Institute
Taiyo Kagaku Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2020 | Year | 12 | Month | 17 | 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
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 05 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048825
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
