UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical trial of blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation) in healthy men and women
Title of the study (Brief title)	Exploratory clinical trial of blood CoQ10 concentration after ingestion of reduced form CoQ10 (self- emulsifying formulation)
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate effects on bioavailability of reduced form CoQ10 (self- emulsifying formulation)
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of reduced form CoQ10 (self- emulsifying formulation) consecutively for one week wash out period Ingestion of reduced form CoQ10 (slurry formulation) consecutively for one week
Interventions/Control_2	Ingestion of reduced form CoQ10 (slurry formulation) consecutively for one week wash out period Ingestion of reduced form CoQ10 (self- emulsifying formulation) consecutively for one week
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy males and females aged 40 to 60 years 2)BMI >=18.5 kg/m2 and <25kg/m2
Key exclusion criteria	1)Subjects who previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder. 2)Subjects who are taking medicine or being treated by a doctor 3)Subjects who are intend to undergo treatment or medication by a doctor during the test period. 4)Subjects who has a soy allergy 5)Subjects who smoke present or have smoked within the last one year prior to the current study 6)Subjects who use specified healthy food, functionality food, supplement. 7)Subjects who are intend to use specified healthy food, functionality food, supplement during the test period. 8)Subjects who perform high exercise intensity with fatigue the next day or sunburn. 9)Women who are pregnant or may be pregnant 10)Women who are breast-feeding 11)Subjects who are planning to participate in other clinical study 12)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	80

Research contact person
Name of lead principal investigator	Hajime Orimo
Organization	Kenkoin Clinic
Division name	Director
Address	6-7-4Ginza, Chuo-ku, Tokyo,104-0061
TEL	03-3573-1153
Email	hajime-orimo@kenkoin.jp

Public contact
Name of contact person	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL	045-820-3659
Homepage URL
Email	tsubokawa_masaya@fancl.co.jp

Sponsor
Institute	Kenkoin Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 10 Day
Anticipated trial start date	2016 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 04 Day
Last modified on	2016 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023593