UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053452 |
|---|---|
| Receipt number | R000060998 |
| Scientific Title | Examination of the Effects of Food Consumption on Oral Environment Improvement |
| Date of disclosure of the study information | 2024/01/26 |
| Last modified on | 2024/01/26 13:33:47 |
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Basic information
Public title
Examination of the Effects of Food Consumption on Oral Environment Improvement
Acronym
Examination of the Effects of Food Consumption on Oral Environment Improvement
Scientific Title
Examination of the Effects of Food Consumption on Oral Environment Improvement
Scientific Title:Acronym
Examination of the Effects of Food Consumption on Oral Environment Improvement
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on the oral environment of a single intake of the test food compared to the consumption of a control food for male and female subjects ranging in age from 40 to 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral bacterial index
Key secondary outcomes
Oral bacterial flora
Caries count, Salivary acidity, Buffering capacity of saliva, White blood cell count, Protein level, Ammonia concentration
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 1 tablet of the test food
Interventions/Control_2
Take 1 tablet of the control food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged 40 to below 65 years at the time of consent acquisition
2. Subjects with concerns about their oral environment
3. Preliminary examination will be conducted on 60 subjects, and those with high scores for "Cariogenic bacteria" and "Leukocyte" in the oral and saliva tests at the time of pre-test will be preferentially included.
4. Subjects who fully understand the purpose and content of the research and voluntarily agree to participate in the research
Key exclusion criteria
1. Subjects who have visited a dentist within 10 days prior to the pre-test, those who are currently visiting a dentist for treatment of periodontal disease, dental caries and those who are scheduled to visit a dentist during the study period.
2. Subjects who routinely use dentures, mouthpieces, or other appliances that require removal and replacement, or orthodontic appliances.
3. Subjects who have undergone or are currently undergoing treatment for dental implants in the past, or who plan to undergo treatment during the research period.
4. Subjects who are judged to be unsuitable as research subjects (subjects) based on the results of preliminary examinations, such as those showing mouth ulcers.
5. Subjects used toothpaste containing hydroxyapatite within one month prior to the pre-test.
6. Subjects who have used mouthwash within one month prior to the pre-test.
7. Subjects who used an interdental brush within 1 month prior to the pre-test.
8. Subjects who have taken antibiotics (antimicrobials) within 3 months prior to the pre-test
9. Subjects who have had a fluoride rinse or application at a dental clinic within one month prior to the pre-test, or those who plan to have a rinse or application during the research period.
10. Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function and have been judged to be unsuitable for participation in the research.
11. Subjects at risk of developing allergies related to the research.
12. Subjects with a disease requiring constant medication (whether topical or oral), those with a disease under treatment (excluding dry eye and eye strain), and those with a history of a serious disease requiring medication treatment.
13. Subjects who work in shifts or late at night and have an irregular rhythm of life.
14. Subjects in other clinical studies, clinical trials, or human trials within one month prior to the start of this research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Asano |
Organization
Unitec Foods Co., Ltd.
Division name
Research & Development Division R & D Group
Zip code
103-0001
Address
14-4 Nihonbashi kodenmacho, Chuoku, Tokyo, Japan
TEL
03-3639-2071
asano.m@unitecfoods.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8, Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8209
Homepage URL
bansho.yoshimi189@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Unitec Foods Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
医療法人社団幸和会（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
15. Subjects who plan to become pregnant or breastfeed during the study period.
16. Subjects who are judged to be inappropriate as research subjects based on their answers to the lifestyle questionnaire.
17. Subjects deemed inappropriate as research subjects by the principal investigator.
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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