UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048973 |
|---|---|
| Receipt number | R000055561 |
| Scientific Title | A study for verification of oral environment-improving and stress-reducing effects by test-food ingestion |
| Date of disclosure of the study information | 2022/09/27 |
| Last modified on | 2023/09/20 12:10:06 |
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Basic information
Public title
A study for verification of oral environment-improving and stress-reducing effects by test-food ingestion
Acronym
A study for verification of oral environment-improving and stress-reducing effects by test-food ingestion
Scientific Title
A study for verification of oral environment-improving and stress-reducing effects by test-food ingestion
Scientific Title:Acronym
A study for verification of oral environment-improving and stress-reducing effects by test-food ingestion
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine some kind of oral environment-improving and stress-reducing effect by test-food intakes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary secretion volume (resting and stimulus)
Key secondary outcomes
1. Simplified questionnaire survey about mental stress (simple ver.: 23 questions)
2. Oral questionnaire
3. Halitosis
4. Cortisol in saliva
5. The Profile of Mood States Second Edition (Japanese short ver.)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food (0.5 mL), twice a day
Interventions/Control_2
Ingestion of the placebo food (0.5 mL), twice a day
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 30 to 69, at informed consent.
(2) Subjects having a subjective symptom of dry mouth and halitosis.
(3) Subjects who feel daily stress.
(4) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., reduced coenzyme Q10-containing)/supplementary/
health foods, which might affect the test results.
(2) Subjects who have taken affecting medicines (e.g., antihistamine/
antidepressant/ antihypertensive/
antiinflammatory/painkiller), and have any difficulty in refraining from taking them during this study.
(3) Subjects who use some kind of oral care product (e.g., mouthwash), and have any difficulty in refraining from using them during this study.
(4) Subjects who have been to the hospital for dental treatment within three months prior to the consent, or those who are now under the treatment (including scaling tartar and plaque).
(5) Subjects who have been diagnosed as dry mouth or Sjogren's syndrome.
(6) Subjects with salivary secretion of no more than 2 g, according to the results of the Saxon tests at the moment of preliminary examination.
(7) Subjects fully realized that their gums are liable to bleed.
(8) Subjects with excessive alcohol intakes.
(9) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(10) Pregnant, lactating, possibly pregnant women during this study.
(11) Subjects having drug/food allergy.
(12) Subjects who are now under other clinical studies with some kind of medicine and/or health food, or partook in those within four weeks before this study, or are going to participate in those after giving informed consent to take part in this study.
(13) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinion.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Tezuka |
Organization
WELLPHARMA Inc.
Division name
Research Team
Zip code
150-0002
Address
1 and 2F JP-Shibuya, 2-4-3 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-6868-8806
yuya_t@wellpharma.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 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
WELLPHARMA Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiyoda Oralhealth Care Clinic
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
| 2022 | Year | 09 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 11 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055561
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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