UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038014 |
|---|---|
| Receipt number | R000042407 |
| Scientific Title | The effects of ubiquinol supplementation on maintaining of cognitive performance and the changes in oral bacterial flora: randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2019/09/17 |
| Last modified on | 2021/02/16 23:51:14 |
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Basic information
Public title
Anti-aging from Wakamiya erea! Wakawaka noukatsu! The strategy for prolonging healthy life expectancy
Acronym
Wakawaka Noukatsu!
Scientific Title
The effects of ubiquinol supplementation on maintaining of cognitive performance and the changes in oral bacterial flora: randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Ubiquinol and cognitive performance: RCT
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ubiquinol supplementation on maintaining cognitive performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive performance
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
Intake of 100 mg ubiquinol after breakfast everyday for 24 weeks.
Interventions/Control_2
Intake of 100 mg placebo capsule after breakfast everyday for 24 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who can participate in the health examination
(2) Those whose age at the time of random allocation is 50 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 of agreement.
(4) Those who consume coenzyme Q10 supplements routinely.
(5) Possibly dementia
(6) Those who have past medical history of celebrovascular disease such as stroke
(7) In addition, those who were judged inadequate by the principal investigator.
Target sample size
110
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
0899047811
tetsu.prospective@gmail.com
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
0899047811
Homepage URL
tetsu.prospective@gmail.com
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
Shitukawa, Toon, Ehime
Tel
089-960-5172
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
| 2019 | Year | 09 | 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
91
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
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2019 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042407
