UMIN-CTR Clinical Trial

Basic information
Public title	Human clinical study on plasma coenzyme Q10 concentrations
Acronym	Human clinical study on plasma coenzyme Q10 concentrations
Scientific Title	Human clinical study on plasma coenzyme Q10 concentrations
Scientific Title:Acronym	Human clinical study on plasma coenzyme Q10 concentrations
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effect of diet on plasma CoQ10 concentrations
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CoQ10 levels
Key secondary outcomes	CoQ10 levels in various areas

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy male and female aged of 20 to 60 years. 2.Subjects who agreed to participate in the study in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study.
Key exclusion criteria	1.Subjects taking supplements containing CoQ10 3 months prior to the study. 2.Subjects who receiving drug treatment. 3.Subjects who participating in any other clinical study/trial or within 4 weeks after participating in another study. 4.Subjects who have history of present illness and past medical history that affect digestion and absorption of diet. 5.Subjects who cannot eat orally. 6.Subjects who are in pregnant, breast feeding, or expect to be pregnant during the study. 7.Subject who have smoking habits. 8.Subjects who continue high-intensity exercise regularly. 9.Subjects judged inappropriate for this study by the principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Iwao Middle name Last name Funahashi
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	5308288
Address	2-3-18, Nakanoshima, Kita-ku, Osaka
TEL	06-6226-5050
Email	Iwao.Funahashi@kaneka.co.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Yamaguchi
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	5308288
Address	2-3-18, Nakanoshima, Kita-ku, Osaka
TEL	050-3133-7356
Homepage URL
Email	Takao.Yamaguchi@kaneka.co.jp

Sponsor
Institute	KANEKA CORPORATION
Institute
Department

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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	info@miura-cl.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	2022 Year 02 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 10 Day
Date of IRB	2021 Year 03 Month 18 Day
Anticipated trial start date	2021 Year 03 Month 22 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Exploratory observational study

Management information
Registered date	2021 Year 03 Month 21 Day
Last modified on	2021 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049888