UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063245 |
|---|---|
| Receipt number | R000072392 |
| Scientific Title | Effects of a dairy ingredient on the oral environment in healthy individuals : a randomized, double-blind, placebo-controlled, crossover superiority trial. |
| Date of disclosure of the study information | 2026/10/12 |
| Last modified on | 2026/10/12 13:58:57 |
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Basic information
Public title
Effects of a dairy ingredient on the oral environment in healthy individuals
: a randomized, double-blind, placebo-controlled, crossover superiority trial.
Acronym
Effects of a dairy ingredient on the oral environment in healthy individuals.
Scientific Title
Effects of a dairy ingredient on the oral environment in healthy individuals
: a randomized, double-blind, placebo-controlled, crossover superiority trial.
Scientific Title:Acronym
Effects of a dairy ingredient on the oral environment in healthy individuals.
Region
| Japan |
Condition
Condition
None (Healthy individuals)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a dairy ingredient on the oral environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacteria count
Key secondary outcomes
Oral discomfort
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
A single intake of dairy ingredient.
Interventions/Control_2
A single intake of placebo.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 to 65 years.
Key exclusion criteria
1)Individuals with diseases of the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system requiring treatment, those with chronic diseases requiring treatment, or those with a history of any serious disease affecting these organs or systems.
2)Individuals who have oral or dental diseases or are receiving treatment for such conditions.
3)Individuals wearing dentures, dental implants, bridges, orthodontic appliances, or other intraoral devices.
4)Individuals who have dysphagia or are suspected of having dysphagia.
5)Individuals who work shifts or are unable to obtain adequate sleep at night for other reasons.
6)Individuals who are unable to discontinue the use of medications or health foods that may affect the oral environment during the study period.
7)Individuals who are unable to refrain from undergoing aesthetic or preventive dental procedures during the study period.
8)Smoker.
9)Extremely heavy drinkers (more than 60g/day of alcohol).
10)Individuals with serious allergies to foods, including milk, or to medications, or those with a history of such allergies.
11)Individuals who are pregnant or under lactation, or who is expected to be pregnant during the study.
12)Individuals who are judged by the principal investigator or principal dentist to be unsuitable for participation in the study based on their background or other relevant considerations.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University of Medical Science
Division name
Department of Pharmacy, Faculty of Pharmaceutical Sciences
Zip code
882-8508
Address
1714-1, Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
h-yoshida@phoenix.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University of Medical Science
Division name
Department of Pharmacy, Faculty of Pharmaceutical Sciences
Zip code
882-8508
Address
1714-1, Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
Homepage URL
h-yoshida@phoenix.ac.jp
Sponsor or person
Institute
Kyushu University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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 at Kyushu University of Medical Science
Address
1714-1, Yoshino, Nobeoka, Miyazaki
Tel
0982-23-5574
h-yoshida@phoenix.ac.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
| 2026 | Year | 10 | Month | 12 | 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
| 2026 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 10 | Month | 12 | Day |
Last modified on
| 2026 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072392
