UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053880 |
|---|---|
| Receipt number | R000061503 |
| Scientific Title | Investigation of the effect of continuous consumption of gummy candies containing reduced coenzyme Q10 on oral-related quality of life with increased saliva secretion. |
| Date of disclosure of the study information | 2024/03/17 |
| Last modified on | 2024/03/17 14:31:26 |
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Basic information
Public title
Investigation of the effect of continuous consumption of gummy candies containing reduced coenzyme Q10 on oral-related quality of life with increased saliva secretion.
Acronym
Investigating the effects of continuous consumption of gummy candies containing reduced coenzyme Q10 on quality of life
Scientific Title
Investigation of the effect of continuous consumption of gummy candies containing reduced coenzyme Q10 on oral-related quality of life with increased saliva secretion.
Scientific Title:Acronym
Investigating the effects of continuous consumption of gummy candies containing reduced coenzyme Q10 on quality of life
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating whether continuous intake of gummies containing reduced coenzyme Q10 increases salivary secretion, thereby causing changes in oral health-related parameters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stimulated saliva production and oral-related quality of life after 8 weeks of test food consumption.
Key secondary outcomes
Oral function test, saliva test, Assessment of eating discomfort and taste, Dietary Variety Score, Test food usage and health awareness survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume 2 gummy candies containing reduced coenzyme Q10 per day for 8 weeks
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons with dry mouth sensation
Age 40 and over
Key exclusion criteria
Persons who are allergic to any of the components of the test food or reagent solution
Those who are taking more than 6 drugs.
Those who are taking drugs with an incidence of 5% or more of those listed as "xerostomia," "dry mouth," or "dysgeusia" in the adverse drug reactions in the package insert information of ethical drugs. If the frequency of occurrence is listed as "frequency unknown" in the accompanying information, the incidence is considered to be less than 5%.
Persons undergoing treatment for xerostomia
Persons with a history of epilepsy, Parkinson's disease, or Sjogren's syndrome, persons who have undergone or will undergo radiation therapy of the head and neck region, and persons who have undergone or will undergo anticancer drug therapy.
Persons who are unable to eat the test food
Person who smokes
Persons who are deemed ineligible by the dentist in charge of the examination
Persons who are deemed ineligible by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MARIKO |
| Middle name | |
| Last name | MAEDA |
Organization
SUNSTAR INC.
Division name
Research and Development Division
Zip code
566-0002
Address
7F, KENTO Innovation Park NK Building, 3-17 Senrioka Shinmachi, Settsu, Osaka
TEL
090-8807-7530
mariko.maeda@jp.sunstar.com
Public contact
Name of contact person
| 1st name | KENTARO |
| Middle name | |
| Last name | IKEDA |
Organization
SUNSTAR INC.
Division name
Research and Development Division
Zip code
566-0002
Address
7F, KENTO Innovation Park NK Building, 3-17 Senrioka Shinmachi, Settsu, Osaka
TEL
090-8807-7530
Homepage URL
kentaro.ikeda@jp.sunstar.com
Sponsor or person
Institute
SUNSTAR INC.
Institute
Department
Personal name
Funding Source
Organization
SUNSTAR INC.
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
SUNSTAR INC. Validity Assessment Committee
Address
3-1 Asahimachi, Takatsuki-shi, Osaka, Japan
Tel
090-8807-7530
takeshi.kanamori@jp.sunstar.com
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
サンスター株式会社 大阪サテライト研究所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 17 | 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
29
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 | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 08 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061503
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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