UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056070 |
|---|---|
| Receipt number | R000063768 |
| Scientific Title | The study of the effects of a test food on saliva secretion |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/27 11:45:24 |
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Basic information
Public title
The study of the effects of a test food on saliva secretion
Acronym
The study of the effects of a test food on saliva secretion
Scientific Title
The study of the effects of a test food on saliva secretion
Scientific Title:Acronym
The study of the effects of a test food on saliva secretion
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of saliva secretion when test food is ingested.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva secretion measurements (at rest and after test food intake)
Key secondary outcomes
Subjective assessment using the Visual Analogue Scale (VAS)
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
Consume one test tablet by allowing it to dissolve in the mouth (on the tongue) without chewing
Interventions/Control_2
Consume one placebo tablet by allowing it to dissolve in the mouth (on the tongue) without chewing
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 40 to below 70 years at the time of consent acquisition.
2.Individuals who are aware that their mouth tends to dry out easily.
3. Individuals with a baseline resting saliva secretion of 1.5 g or more during preliminary testing.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who consume foods or supplements containing dihydrocapsiate, coenzyme Q10, eriodictyol-6-C-glucoside, or similar compounds that could affect the trial, including Foods with Function Claims, functional food labels, and health supplements, more than once a week and cannot discontinue their use from the time of consent.
2. Individuals who cannot discontinue the intake of dihydrocapsiate, coenzyme Q10, eriodictyol-6-C-glucoside, or similar compounds included in Foods with Function Claims, functional food labels, and health supplements from the time of consent.
3. Individuals who are taking medications that could affect the trial, such as antihypertensives, antihistamines, antiepileptics, anti-Parkinson drugs, and sedatives.
4. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
5. Smokers, except for those who have abstained from smoking for more than one year.
6. Individuals with excessive alcohol intake.
7. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
8. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
9. Individuals with allergies to medications and/or food.
10. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
40
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, 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, 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
Senju Pharmaceutical 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
| 2025 | Year | 08 | Month | 27 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063768
