UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032814 |
|---|---|
| Receipt number | R000037276 |
| Scientific Title | The effects of ubiquinol intake on maintaining or improving of cognitive performance and total health |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2023/12/04 09:12:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of ubiquinol intake on maintaining or improving of cognitive performance and total health
Acronym
Ubiquinol Health Examination
Scientific Title
The effects of ubiquinol intake on maintaining or improving of cognitive performance and total health
Scientific Title:Acronym
Ubiquinol Health Examination
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of long-term uniquinol intake on improving the congitive performance among community residents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive performance (Trail Making Test)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants ingest 150 mg of ubiquinol once a day after a meal. Participants can continue as long as they wish until May of 2022. The routine health examination is given every six months during the study period, at which times new participants can join this study.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who can participate in the Ubiquinol Health Examination every six months held in Kamijima town, Ehime prefecture.
(2) Those whose age at the time of informed consent is 20 and over.
(3) Those who can understand the purpose and the contents of this study, and can agree with participation by letter.
Key exclusion criteria
(1) The presence of allergic response to test foods.
(2) Pregnancy or beast-feeding.
(3) Those who participated in other clinical trials within three months.
(4) Those who consume coenzyme Q10 supplements routinely.
(3) In addition, those who were judged inadequate by the principal investigator.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
791-0243
Address
1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL
089-904-7811
tetsu@shin-science.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
791-0243
Address
1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL
089-904-7811
Homepage URL
tetsu@shin-science.co.jp
Sponsor or person
Institute
Institute of Community Life Sciences Co., Ltd.
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
Institutional Review Board (IRB) of Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
0899605172
rinri@m.ehime-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
| 2018 | Year | 05 | Month | 31 | 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
188
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
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037276
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
