UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057380 |
|---|---|
| Receipt number | R000065569 |
| Scientific Title | Study on the intervention of agarooligosaccharides on the oral environment in adult male and female subjects |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/03/24 17:20:07 |
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Basic information
Public title
Study on the intervention of research food components on the oral environment in adult male and female subjects
Acronym
Study on the intervention of research food components on the oral environment in adult male and female subjects
Scientific Title
Study on the intervention of agarooligosaccharides on the oral environment in adult male and female subjects
Scientific Title:Acronym
Study on the intervention of agarooligosaccharides on the oral environment in adult male and female subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on the oral environment of mouthrinse containing research food component (agarooligosaccharides or combination with erythritol) as compared to the placebo mouthrinse.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in microbiota composition and diversity in the oral cavity between research-food-component-containing-mouthrinse intervention and placebo
Key secondary outcomes
Change in questionnaires responses between research-component-containing-mouthrinse intervention and placebo
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Mouth-rinsing using research-food-component-non-containing-mouthrinse.
Interventions/Control_2
Mouth-rinsing using research-food-component-cointaining-mouthrinse.
Interventions/Control_3
Mouth-rinsing using research-food-component-cointaining-mouthrinse.
Interventions/Control_4
Mouth-rinsing using research-food-component-cointaining-mouthrinse.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals aged 18 to under 70.
(2) Individuals who do not have any oral, dental, or gum diseases (not diagnosed with periodontitis or periodontal disease) and are concerned about their oral condition but do not require immediate treatment.
(3) Individuals who fully understand the purpose and content of the study and voluntarily consent to participate in the research.
Key exclusion criteria
(1) Individuals diagnosed with oral diseases including periodontitis and other periodontal diseases, and those who are scheduled for dental treatment on the day of implementation.
(2) Individuals who regularly consume (three or more times a week) products containing oligosaccharides such as agarooligosaccharides, or have done so within the three months prior to the pre-test.
(3) Individuals diagnosed with malignancies, or those undergoing treatment for neurological disorders, heart disease, kidney disease, diabetes, thyroid dysfunction, or those with a history of severe liver diseases. However, diseases deemed by the principal investigator to have no impact on this study's evaluation, such as treatment for hypertension, are excluded.
(4) Individuals who consume large amounts of alcohol (equivalent to 60 g of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 go [about 540 mL] of sake, or 180 mL of whiskey).
(5) Individuals who are at risk of developing allergies related to the study products.
(6) Individuals judged to be unsuitable as subjects based on responses to the lifestyle questionnaire.
(7) Individuals who participated in another clinical study within one month prior to obtaining consent for this study, or those planning to participate in another clinical study after obtaining consent.
(8) Other individuals deemed unsuitable as subjects by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Shiba |
Organization
Ina Food Industry Co., Ltd.
Division name
Development Division
Zip code
399-4498
Address
5074 Nishiharuchika, Ina, Nagano, Japan
TEL
0265-78-1121
kshiba@kantenpp.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Karasawa |
Organization
Ina Food Industry Co., Ltd.
Division name
Research and Development Department, Development Division
Zip code
399-4498
Address
5074 Nishiharuchika, Ina, Nagano, Japan
TEL
0265781121
Homepage URL
k-kouji@kantenpp.co.jp
Sponsor or person
Institute
Ina Food Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board
Address
1-14-26-204 Mihara-dai, Nerima-ku, Tokyo, Japan
Tel
080-7345-7947
info@okutoeru.com
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
| 2025 | Year | 03 | Month | 24 | 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
20
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
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065569
