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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029160
Receipt No. 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

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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
Email 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
Email Kenji.Fujii@Kaneka.co.jp

Sponsor
Institute Shakotan-cyo office
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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