UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056745 |
|---|---|
| Receipt number | R000064850 |
| Scientific Title | A study to verify the effects of test food intake on saliva secretion volume and quality |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2025/01/17 16:00:08 |
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Basic information
Public title
A study to verify the effects of test food intake on saliva secretion volume and quality
Acronym
A study to verify the effects of test food intake on saliva secretion volume and quality
Scientific Title
A study to verify the effects of test food intake on saliva secretion volume and quality
Scientific Title:Acronym
A study to verify the effects of test food intake on saliva secretion volume and quality
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food intake on saliva secretion volume and quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unstimulated saliva secretion volume
Key secondary outcomes
Stimulated saliva secretion secretion (saxon test), viscosity of saliva,salivary pH, buffer capacity, and Visual Analogue Scale (oral dryness and stickiness)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for 4 weeks
Interventions/Control_2
Daily intake of placebo food 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 or more and 64 or less
2) Subjects who can give informed consent to participate in this study
Key exclusion criteria
1) Subjects who are allergic to the test food
2) Subjects who are undergoing medical treatment for diseases related to decreased saliva secretion, such as Sjogren's syndrome and salivary gland disorders
3) Subjects who are undergoing medical treatment that cause dry mouth as a side effect, such as medications for mental disorders or urinary disorders.
4) Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, liver cirrhosis, and diabetes.
5) Subjects who regularly take supplements containing antioxidants
6) Subjects who regularly take Herbal medicines, supplements, food, beverages affecting dry mouth, such as the reduced form of Coenzyme Q10.
7) Subjects who are pregnant or lactating, or intending to become pregnant during the study
8) Subjects who took part in another clinical study within 28 days prior to the start of the present study or who are currently taking part in another clinical study
9) Subjects who are judged as ineligible to participate in this study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Maruo |
Organization
Fujicco Co., Ltd
Division name
Innovation center
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5385
t-maruo@fujicco.co.jp
Public contact
Name of contact person
| 1st name | Toshinari |
| Middle name | |
| Last name | Maruo |
Organization
Fujicco Co., Ltd
Division name
Innovation center
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5385
Homepage URL
t-maruo@fujicco.co.jp
Sponsor or person
Institute
Fujicco Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujicco 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
Ethics Committee, Fujicco
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-303-5385
research@fujicco.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
フジッコ株式会社（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064850
