UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024406
Receipt No. 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 (Ver. 10)

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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)
Email 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
Email Kenji.Fujii@kaneka.co.jp

Sponsor
Institute Tsurumi University School of Dental Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028087