UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of health enhancement and QOL improvement effect by continuous ubiquinol ingestion
Title of the study (Brief title)	QH Island Project
Region	Japan

Condition
Condition	Nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this project is to evaluate the health enhancement and QOL improvement effect by carrying out continuous intake of ubiquinol, and contribute to a local resident's healthy life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL score (SF-36)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Participants ingest 120 mg of ubiquinol once a day after a meal. Participants can continue as long as they wish until November of 2017. A routine health check is given every six months during the study period, at which times new participants can join the study.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Those who live in Kamijima town, Ehime prefecture. (2) Those whose age at the time of informed consent is 20 and over. (3) Those who can understand the purpose and the contents of this study, and can agree with participation by letter.
Key exclusion criteria	(1) The presence of allergic response to test foods. (2) Pregnancy or beast-feeding. (3) In addition, those who were judged inadequate by investigator.
Target sample size	500

Research contact person
Name of lead principal investigator	Tetsu Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	089-904-7811
Email	tetsu.prospective@gmail.com

Public contact
Name of contact person	Tetsu Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	089-904-7811
Homepage URL
Email	tetsu.prospective@gmail.com

Sponsor
Institute	Institute of Community Life Sciences Co., Ltd.
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)

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	2014 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 11 Month 17 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 17 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014644