UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051922 |
|---|---|
| Receipt number | R000059241 |
| Scientific Title | Effect of plant extract intake on the oral environment of healthy adults |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2023/08/18 11:20:46 |
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Basic information
Public title
Effect of plant extract intake on the oral environment of healthy adults
Acronym
Effects of plant extract Intake on the oral environment
Scientific Title
Effect of plant extract intake on the oral environment of healthy adults
Scientific Title:Acronym
Effects of plant extract Intake on the oral environment
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to determine the effect on the oral environment of daily consumption of plant extract by adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Environment Indices
Key secondary outcomes
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
Receiving 27 mg of plant extract as active component daily group
Interventions/Control_2
Placebo group
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Able-bodied persons aged 20 to 64 at the time of obtaining the consent form
2. Persons with no history of hypersensitivity to grape and/or dextrin
3. Have not been a smoker for at least one year
4. No history of epilepsy, diabetes, cerebrovascular disease, cardiovascular disease, cancer, or paralysis
5. No daily use of medications that may affect this study (Listerine or other antibacterial mouth rinses, antibiotics, or gargles)
6. No oral diseases for which treatment is available
7. Those who have not undergone dental maintenance (plaque and tartar removal) within the past 3 months
8. Have 20 or more teeth
9. Not pregnant, not intending to become pregnant during the examination period, and not breast-feeding
10. Those who have not participated or are not currently participating in any other clinical research within 3 months
11. Those who fully understand the content of this study and are able to commute to the site of this study on their own
Key exclusion criteria
1. Those who use health foods or supplements that may affect this study within 3 months
2. Those who used medicines (antibacterial oral rinses and antibiotics such as Listerine, and gargles) that may affect this study within 2 weeks prior to the start of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Aida |
| Middle name | |
| Last name | Kazuhiko |
Organization
NIPPN Corporation
Division name
Central Research Laboratory, Innovation Center,
Zip code
243-0041
Address
5-1-3, Midorigaoka, Atsugi, Kanagawa
TEL
046-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Shimazu |
Organization
NIPPN Corporation
Division name
Central Research Laboratory, Innovation Center
Zip code
243-0041
Address
5-1-3, Midorigaoka, Atsugi, Kanagawa
TEL
046-222-6963
Homepage URL
k-shimazu@nippn.co.jp
Sponsor or person
Institute
NIPPN Corporation
Institute
Department
Personal name
Funding Source
Organization
NIPPN Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NIPPN Corporation
Address
5-1-3, Midorigaoka, Atsugi, Kanagawa
Tel
046-222-6963
k-shimazu@nippn.co.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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059241
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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