UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041872 |
|---|---|
| Receipt number | R000047697 |
| Scientific Title | Study to estimate the efficacy of reduced form of coenzyme Q10 (ubiquinol) for maintaining good health in healthy paersons by open labbeled test. |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2025/03/28 09:16:39 |
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Basic information
Public title
Study to estimate the efficacy of reduced form of coenzyme Q10 (ubiquinol) for maintaining good health in healthy paersons.
Acronym
Ubiquinol efficacy for maintaining good health in healthy persons
Scientific Title
Study to estimate the efficacy of reduced form of coenzyme Q10 (ubiquinol) for maintaining good health in healthy paersons by open labbeled test.
Scientific Title:Acronym
Ubiquinol efficacy for maintaining good health.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy of reduced form of coenzyme Q10 (unbiquinol) for health management of employee of Kaneka Corporation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL (fatigue, stress, sleep)
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
reduced form of coenzyme Q10 (
ubiquinol), 100mg/day, two years
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
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Empolyee of Kaneka Corporation
(2) Possible to join the regularly health check.
(3) Over 18 years old.
Key exclusion criteria
(1) Persons who have allegy to ubiquinol.
(2) Under medication or take supplement which has same efficacy of ubiquinol.
(3) Patience of cancser or such seruous disease.
(4) Doctor did not allow to entry to this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Sakamoto |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition SV
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo
TEL
03-5574-8000
Yoshitomo.Sakamoto@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
7910243
Address
1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL
089-904-7811
Homepage URL
tetsu@shin-science.co.jp
Sponsor or person
Institute
Kaneka Corporation
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
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
KSO Corporation
Address
1-9-7, Shibaura, Minato-ku, Tokyo
Tel
03-3542-7733
shiken@kso.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
| 2020 | Year | 09 | Month | 30 | 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
120
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047697
