UMIN-CTR Clinical Trial

Basic information
Public title	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) to fatigue
Acronym	Anti-fatigue effect of Reduced form of Coenzyme Q10
Scientific Title	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) to fatigue
Scientific Title:Acronym	Anti-fatigue effect of Reduced form of Coenzyme Q10
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy of Reduced form of Coenzyme Q10 to several biological parameters relates to fatigue
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autonomic nervous system, Oxidation stress, Antioxidant activity, Cognitive function, Condition of sleep, VAS(fatigue), These items will be determined at 0, 4, 8 and 12 weeks.
Key secondary outcomes	Physical active mass

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Reduced form of Coenzyme Q10 ( 100mg/day), 3months, 25 healthy person.
Interventions/Control_2	Reduced form of Coenzyme Q10(150mg/day), 3months, 25 healthy person.
Interventions/Control_3	Placebo, 3months, 25 healthy person
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.age:over 20 y.o 2.healthy person
Key exclusion criteria	1.Under medication. 2.Take coenzyme Q10 supplement. 3.Take medicine that might impact the outcome measures. 4.Patient of serious disease such as diabetes, live disease, renal disease, heart disease, mental disease, disease to become the motive of fatigue, cardiovascular, nerve, allergy, insomnia. 5.Pregnant and women who wish to pregnant in this study period. 6.alcholism 7.Doctor did not allow to entry to this study. 8.Entry another clinical study which ongoing or performed within 1 month.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuyoshi Watanabe
Organization	Osaka City University
Division name	Center for Health Science Innovation,
Zip code
Address	9F,Tower-C,Knowledge Capital,Grand Front Osaka,3-1,Ofuka-cho,Kita-ku,Osaka, Japan, Zip 530-0011
TEL	06-6485-0288
Email	chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenji Fujii
Organization	KANEKA CORPORATION
Division name	QOL Division
Zip code
Address	1-12-32, Akasaka, Minato-ku, Tokyo, Japan, Zip107-6025
TEL	03-5574-8112
Homepage URL
Email	Kenji.Fujii@kaneka.co.jp

Sponsor
Institute	Center for Health Science Innovation, Osaka City University
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪市立大学健康科学イノベーションセンター Center for Health Science Innovation, Osaka City University

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 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
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	2015 Year 12 Month 04 Day
Date of IRB	2015 Year 12 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 26 Day
Last modified on	2020 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024160