UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050403 |
|---|---|
| Receipt number | R000057391 |
| Scientific Title | Evaluation study on the oral environment and safety of long-term intake of test foods |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2023/08/22 09:16:31 |
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Basic information
Public title
Evaluation study on the oral environment and safety of long-term intake of test foods
Acronym
Evaluation study on the oral environment and safety of long-term intake of test foods
Scientific Title
Evaluation study on the oral environment and safety of long-term intake of test foods
Scientific Title:Acronym
Evaluation study on the oral environment and safety of long-term intake of test foods
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate of the oral environment of intake of the test food for 4 weeks and the safety of intake of the test food for 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque index
Key secondary outcomes
Tongue coating assessment
Gingivitis index
Oral bacteria
VAS questionnaire
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
Consume 1 tablets of the test food daily for 12 weeks.
Interventions/Control_2
Consume 1 tablets of the placebo food daily for 12 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese who are 18 years old or more and under 65 years old
3.Persons who have problems with the oral environment
4.Persons who are the top of plaque index at screening
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who regularly take a large amount of the test food
4.Persons who regularly use toothpaste containing an ingredient in test food within 30 days of the start of the study.
5.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect the oral environment
6.Persons who are wearing dentures, replacement teeth, implants, bridges, orthodontic wires.
7.Persons who treatment for periodontal disease or dental caries.
8.Persons who undergoing dental treatment or suffer from dental disease.
9.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
10.Persons who were judged as inappropriate for study participants by the principal investigator
11.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Unitec Foods Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 02 | Month | 21 | 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
60
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 | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 06 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057391
| 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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