UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024406 |
|---|---|
| Receipt number | R000028087 |
| Scientific Title | Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2019/07/30 17:05:23 |
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Basic information
Public title
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people
Acronym
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people
Scientific Title
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people
Scientific Title:Acronym
Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) gummi on oral function in healthy people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CoQ10 concentration in saliva
Amount of saliva secretion
Anti-oxidative activity of saliva
Oxidative stress in saliva
RSST
biting force
These items will be determined at 0,8weeks after intake.
Key secondary outcomes
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
Reduced form of Coenzyme Q10 (Ubiquinol) gummi, 100mg/day,
8 weeks.
Interventions/Control_2
Placebo gummi,
8 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are healthy 20-65 years old person.
Key exclusion criteria
1.under medication
2.take medicine and food that might impact the outcome measure
3.Patient of serious disease such as liver disease,renal disease,heart disease,cancer
4.Pregnant and women who wish to pregnant in this study period
5.Sjogren's syndrome patients
6.The person that the eating habits are extremely irregular, Person of shift work, Person of graveyard shift
7.The person indicating the allergic reaction to experimental diet
8.The person entry another clinical study which ongoing or within four weeks after other clinical study end or with the plan to participate in other clinical study
9.Doctor did not allow to entry to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Saito |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Pathology
Zip code
230-8501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL
045-580-8360(8362)
saito-i@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenj |
| Middle name | |
| Last name | Fujii |
Organization
KANEKA CORPORATION
Division name
QOL Division
Zip code
107-0052
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
03-5574-8112
Homepage URL
Kenji.Fujii@kaneka.co.jp
Sponsor or person
Institute
Tsurumi University School of Dental Medicine
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committees of Tsurumi University
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
Tel
045-581-1001
rinrishinsa@tsurumi-u.ac.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
| 2016 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
https://doi.org/10.1371/journal.pone.0214495.s002
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0214495
Number of participants that the trial has enrolled
40
Results
At the end of study, along with a significant increase of
the CoQ10 level in saliva (p = 0.025*, d = 0.65), there
was a significant increase of the saliva flow rate
(p = 0.048*, d = 0.66) in the ubiquinol candy group
compared to the placebo group.
Results date posted
| 2019 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
placebo group (n=18; 47.4 plus minus 6.2 years; 6 men and 12 women)
Saliva flow rate (g/2min): 4.40 plus minus1.46
Salivary CoQ10 level (maicrogram/ml): 84.5 plus minus 92.3
RSST : 5.35 plus minus 1.30
Bite force (right) : 0.33 plus minus 0.20
Bite force (left) : 0.33 plus minus 0.21
ubiquinol candy group (n=20; 52.2 plus minus 7.7 years; 4 men and 16 women)
Saliva flow rate (g/2min) : 5.18 plus minus 1.76
Salivary CoQ10 level (maicrogram/ml): 105.7 plus minus 243.7
RSST : 5.89 plus minus 2.38
Bite force (right) : 0.40 plus minus 0.18
Bite force (left) : 0.43 plus minus 0.20
Participant flow
Inclusion: 40
Exclusion: 1
Allocation (randomization): 39
Placebo group: 20
Ubiquinol Candy Group: 19
Analysis object
Placebo group: 20 people
Ubiquinol candy group: 18 people (excluded 1)
Adverse events
No serious adverse events
Outcome measures
Saliva flow rate (g/2 min)
Placebo
0w : 4.4 plus minus 1.46
8w : 4.81 plus minus 1.66
Ubiquinol
0w : 5.18 plus minus 1.76
8w : 6.02 plus minus 1.88 **p<0.01
Salivary CoQ10 level (microgram/ml)
Placebo
0w : 84.5 plus minus 92.3
8w : 139 plus minus 213
Ubiquinol
0w : 105.7 plus minus 243.7
8w : 536.2 plus minus 834.4 **p<0.01
RSST
Placebo
0w : 5.35 plus minus 1.30
8w : 7 plus minus 2.43
Ubiquinol
0w : 5.89 plus minus 2.38
8w : 6.72 plus minus 3.30
Bite force (right)
Placebo
0w : 0.33 plus minus 0.20
8w : 0.36 plus minus 0.20
Ubiquinol
0w : 0.4 plus minus 0.18
8w : 0.47 plus minus 0.18
Bite force (left)
Placebo
0w : 0.33 plus minus 0.21
8w : 0.37 plus minus 0.21
Ubiquinol
0w : 0.43 plus minus 0.208
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028087
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