UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052628 |
|---|---|
| Receipt number | R000060042 |
| Scientific Title | Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion |
| Date of disclosure of the study information | 2024/10/27 |
| Last modified on | 2024/04/23 18:22:04 |
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Basic information
Public title
Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion
Acronym
Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion
Scientific Title
Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion
Scientific Title:Acronym
Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of a single intake of the test food on increasing salivary secretion volume.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in resting salivary volume
Key secondary outcomes
VAS for mouth dryness
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
Consumption one tablet of the test food
Interventions/Control_2
Consumption one tablet of the placebo food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 20 to 64 years old.
2. Subjects with resting salivary secretion of more than 1.5 g.
3. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health foods (including supplements) more than three times a week, which may potentially affect the study, and are unable to discontinue from the time of consent acquisition.
2. Subjects who are taking the following medications more than two days a week and cannot restrict their use during the study period, as they may potentially affect the study:
Antihistamines
Cold medicines (e.g., Contac 600)
Medicines that suppress stomach acid: H2 blockers (e.g., Gaster 10), proton pump inhibitors (e.g., Takepron, Takecab)
Hypertension drugs: Calcium antagonists (e.g., Adalat)
Medications for frequent urination (e.g., BUP-4)
Antipsychotic drugs, anti-anxiety drugs, sleep medications
Other medications that may cause oral dryness
3. Subjects who, at the time of consent acquisition, have plans for oral treatments such as dental treatments or oral cleanings during the study period.
4. Subjects who have been diagnosed with dry mouth or Sjogren's syndrome.
5. Subjects who are in the habit of smoking, or have been in the habit of smoking within the past year.
6. Subjects with excessive alcohol intake.
7. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
8. Subjects with severe or progressive pre-existing conditions or symptoms.
9. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
10. Subjects having some kind of drug and/or food allergy.
11. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
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 | Makoto |
| Middle name | |
| Last name | Ichinohe |
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
Meiji Holdings 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 | 10 | 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
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060042
