UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050090 |
|---|---|
| Receipt number | R000056732 |
| Scientific Title | Verification research of oral environment-improving effects by test-food consumption |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2023/11/24 13:45:09 |
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Basic information
Public title
Verification research of oral environment-improving effects by test-food consumption
Acronym
Verification research of oral environment-improving effects by test-food consumption
Scientific Title
Verification research of oral environment-improving effects by test-food consumption
Scientific Title:Acronym
Verification research of oral environment-improving effects by test-food consumption
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of oral environment-improving 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 (Saxon test)
Key secondary outcomes
1. Oral bacteria (caries-related bacteria; Total Streptococci, Mutans Streptococci, Lactobacillaceae, and periodontal disease-related bacteria; Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythensis, Treponema denticola, Fusobacterium nucleatum)
2. Questionnaire (Visual Analogue Scale)
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
Ingesting a drop of the test food, once a day
Interventions/Control_2
Ingesting a drop of the placebo food, once 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 18 to 69, at informed consent.
(2) Subjects having a subjective symptom of dry mouth.
(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
Subjects - -
(1) who take steadily (over 3 times a week) in affecting health-specific/functional (e.g., reduced coenzyme Q10, L. reuteri)/supplementary/health foods,
(2) who have taken affecting medicines (e.g., anti-biotic/fungal/histamine/hypertensive), and have any difficulty in refraining from taking them during this research,
(3) who use an oral care product (e.g., mouthwash), except for toothbrush/paste, and have any difficulty in refraining from using them during this research,
(4) who have been to the hospital for dental treatment within 3 months prior to the consent, or those who are now under the treatment (including scaling tartar and plaque),
(5) with salivary secretion of less than 2 g at pre-test,
(6) who have been diagnosed as dry mouth or Sjogren's syndrome,
(7) fully realized that their gums are liable to bleed,
(8) equipped with full dentures,
(9) with smoking (including no smoking less than 1 year),
(10) with excessive alcohol intakes,
(11) who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases,
(12) with pregnancy, possibly one, or lactating,
(13) having drug/food allergy,
(14) who are now under other clinical studies with medicine or health food, or partook in those within 4 weeks before this research,
(15) who donated over 0.2 L of their blood and/or blood components within a month to this research,
(16) who donated his whole blood (0.4 L) within the last 3 months to this research,
(17) who donated her whole blood (0.4 L) within the last 4 months to this research,
(18) who will be collected in total of his blood (1.2 L) within the last 12 months, after adding the blood amounts planning to be sampled in this research,
(19) who will be collected in total of her blood (0.8 L) within the last 12 months, after adding the blood amounts planning to be sampled in this research,
(20) who have been determined as ineligible for participation, judging from the principal/sub investigator - - .
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Yamauchi |
Organization
ORYZA OIL & FAT CHEMICAL
Division name
Sub-section manager
Zip code
491-0000
Address
1 Kitagata-Cho-Numata, Ichinomiya-shi, Aichi 491-0000, Japan
TEL
0586-86-5141
seigi@oryza.co.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Kobayashi |
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
ORYZA OIL & FAT CHEMICAL
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 | 01 | Month | 24 | 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 | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 16 | 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 | 01 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056732
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| Registered date | File name |
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