UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029160 |
|---|---|
| Receipt number | R000033307 |
| Scientific Title | Verification of health enhancement by continuous reduced form of CoQ10 (ubiquinol) ingestion. |
| Date of disclosure of the study information | 2017/09/21 |
| Last modified on | 2019/10/04 10:54:42 |
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Basic information
Public title
Verification of health enhancement by continuous reduced form of CoQ10 (ubiquinol) ingestion.
Acronym
Ubiquinol monitoring in Shakotan
Scientific Title
Verification of health enhancement by continuous reduced form of CoQ10 (ubiquinol) ingestion.
Scientific Title:Acronym
Ubiquinol monitoring in Shakotan
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the health enhancement activity of reduced form of coenzyme Q10 (ubiquinol).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL, cognitive function, activity, sereu CoQ10 concentration, blood biochemistry test
Compare before intake with after 3 month intake
Key secondary outcomes
Sleepness
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Foods contain reduced form of CoQ10
100-150mg/day
3 months
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) residents of Shakortane-cyo
(2) 20 -90 age
(3) Person have ability of judge for this study.
Key exclusion criteria
(1)Have allergenic reaction for test foods
(2)Take medicine or supplement may effect this study.
(3)During medication of serious disease such as cancer.
(4)pregnant woman
(5)Person can not write anquestionare by themself.
(6)Docter do not peemit to join this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Fujii |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition SV
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo
TEL
050-3133-6752
Kenji.Fujii@Kaneka.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Fujii |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition SV
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo
TEL
050-3133-6752
Homepage URL
Kenji.Fujii@Kaneka.co.jp
Sponsor or person
Institute
Shakotan-cyo office
Institute
Department
Personal name
Funding Source
Organization
Cabinet office
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SAPPORO YURINOKAI HOSPITAL
Address
11-186, Yurigahara, Kita-ku, Sapporo-city, Japan
Tel
011-771-1501
k-ohno@cli-creative.com
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
| 2017 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033307
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
