UMIN-CTR Clinical Trial

Basic information
Public title	Anti-aging from Wakamiya erea! Wakawaka noukatsu! The strategy for prolonging healthy life expectancy
Acronym	Wakawaka Noukatsu!
Scientific Title	The effects of ubiquinol supplementation on maintaining of cognitive performance and the changes in oral bacterial flora: randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	Ubiquinol and cognitive performance: RCT
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of ubiquinol supplementation on maintaining cognitive performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cognitive performance
Key secondary outcomes

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of 100 mg ubiquinol after breakfast everyday for 24 weeks.
Interventions/Control_2	Intake of 100 mg placebo capsule after breakfast everyday for 24 weeks.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Those who can participate in the health examination (2) Those whose age at the time of random allocation is 50 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) Those who participated in other clinical trials within three months of agreement. (4) Those who consume coenzyme Q10 supplements routinely. (5) Possibly dementia (6) Those who have past medical history of celebrovascular disease such as stroke (7) In addition, those who were judged inadequate by the principal investigator.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Tetsu Middle name Last name Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Zip code	791-0243
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	0899047811
Email	tetsu.prospective@gmail.com

Public contact
Name of contact person	1st name Tetsu Middle name Last name Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Zip code	791-0243
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	0899047811
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)

IRB Contact (For public release)
Organization	Institutional Review Board (IRB) of Ehime University Hospital
Address	Shitukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.ac.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	2019 Year 09 Month 17 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	91
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	2019 Year 08 Month 26 Day
Date of IRB	2019 Year 08 Month 26 Day
Anticipated trial start date	2019 Year 09 Month 21 Day
Last follow-up date	2020 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	2019 Year 09 Month 14 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042407