UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053446 |
|---|---|
| Receipt number | R000060898 |
| Scientific Title | Evaluation Trial on the Effects of Test Food Consumption on Oral Environment Improvement |
| Date of disclosure of the study information | 2024/01/28 |
| Last modified on | 2024/01/21 12:24:40 |
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Basic information
Public title
Evaluation Trial on the Effects of Test Food Consumption on Oral Environment Improvement
Acronym
Evaluation Trial on the Effects of Test Food Consumption on Oral Environment Improvement
Scientific Title
Evaluation Trial on the Effects of Test Food Consumption on Oral Environment Improvement
Scientific Title:Acronym
Evaluation Trial on the Effects of Test Food Consumption on Oral Environment Improvement
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on the oral environment of continuous consumption of the test food product over a period of 4 weeks, compared to the consumption of a control food product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depth of periodontal pockets
Key secondary outcomes
Saliva volume
Presence of bleeding on probing
Plaque index
TCI (Tongue Coating Index) score
Oral bacterial counts
Subjective questionnaire
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
Consumption of the test food (1 tablet a day) for 4 weeks
Interventions/Control_2
Consumption of the placebo food (1 tablet a day) for 4 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged 25 to below 65 years at the time of consent acquisition.
2. Subjects with concerns about their oral environment.
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume Food for Specified Health Uses (FOSHU) or Foods with Function Claims (including products containing reduced coenzyme Q10, Lactobacillus reuteri, and Gekkeiju leaf extract), or health supplements (including supplements), which might affect the oral environment, more than three times a week, and cannot discontinue them from the time of consent acquisition.
2. Subjects taking medications (such as antibiotics, antifungal drugs, antihistamines, antihypertensives) that may affect the trial, and cannot restrict their use from the time of consent acquisition.
3. Subjects using oral care products other than toothbrushes and toothpaste (such as mouthwash) and cannot restrict their use from the time of consent acquisition.
4. Subjects who regularly use toothpaste containing hydroxyapatite.
5. Subjects who have undergone dental treatment (including tartar cleaning and plaque cleaning) within three months prior to consent acquisition or are currently undergoing dental treatment.
6. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
7. Subjects using dental implants.
8. Subjects using partial dentures or bridges in two or more locations.
9. Subjects undergoing orthodontic treatment.
10. Subjects with excessive alcohol intake.
11. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
12. Females who are pregnant or lactating, and females who could become pregnant during trial period.
13. Subjects with allergies to medications and/or food.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Unitec Foods 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 28 | 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 | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
14. Subjects who donated blood or component (200 mL) within the last 1 months.
15. Subjects who donated his blood (400 mL) within the last 3 months.
16. Subjects who donated her blood (400 mL) within the last 4 months.
17. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study.
18. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
19. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060898
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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