UMIN-CTR Clinical Trial

Basic information
Public title	Investigate the relationship between the individual differences in the effects of continuous ubiquinol (reduced CoQ10) supplementation on improving QOL and cognitive function and the single nucleotide polymorphisms in CoQ10 metabolism-related genes.
Acronym	Investigation of the relationship between the individual differences in the effects of continuous ubiquinol supplementation on improving QOL and cognitive function and the single nucleotide polymorphisms.
Scientific Title	Investigate the relationship between the individual differences in the effects of continuous ubiquinol (reduced CoQ10) supplementation on improving QOL and cognitive function and the single nucleotide polymorphisms in CoQ10 metabolism-related genes.
Scientific Title:Acronym	Investigation of the relationship between the individual differences in the effects of continuous ubiquinol supplementation on improving QOL and cognitive function and the single nucleotide polymorphisms.
Region	Japan

Condition
Condition	Nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	It was found that the increased serum CoQ10 levels after continuous ubiquinol supplementation were affected by the single nucleotide polymorphisms (SNP) in the participants of the "Verification of health enhancement and QOL improvement effect by continuous ubiquinol ingestion (Ubiquinol Health Examination)" study (UMIN000012612). These SNPs are involved in CoQ10 and cholesterol metabolism/absorption-related genes. This project aimed to search for the involvement of the above SNPs in the QOL- and cognitive function-improvement by ubiquinol supplementation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between SNPs and SF-36 by the continuous ubiquinol supplementation
Key secondary outcomes	Relationship between SNPs and Digit Symbol Substitution Test by the continuous ubiquinol supplementation

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	Not applicable
Gender	Male and Female
Key inclusion criteria	One hundred seventy people participated in the "Relationship between the absorption of ubiquinol supplement and the genetic diversity for participants in the Ubiquinol Health Examination (SNP Study)" (2016) and in the Ubiquinol Health Examination (from 2013 to 2018). The SNP Study was approved by the Wayo Women's University Human Research Ethics Committee (No. 1614).
Key exclusion criteria	Those who were assessed to have a low intake rate of ubiquinol supplement based on serum CoQ10 levels in this study
Target sample size	170

Research contact person
Name of lead principal investigator	1st name Toshikazu Middle name Last name Suzuki
Organization	Wayo Women's University
Division name	Department of Health and Nutrition
Zip code	272-8533
Address	Konodai 2-3-1, Ichikawa, Chiba
TEL	043-371-1547
Email	t-suzuki@wayo.ac.jp

Public contact
Name of contact person	1st name Toshikazu Middle name Last name Suzuki
Organization	Wayo Women's University
Division name	Department of Health and Nutrition
Zip code	272-8533
Address	Konodai 2-3-1, Ichikawa, Chiba
TEL	043-371-1547
Homepage URL	https://wayonutrsuzukilab.wixsite.com/biochem
Email	t-suzuki@wayo.ac.jp

Sponsor
Institute	Wayo Women's University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institute of Community Life Sciences Co., Ltd. Kaneka Co.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wayo Women's University Human Research Ethics Committee
Address	2-3-1 Konodai, Ichikawa, Chiba
Tel	047-371-1184
Email	k-shien@wayo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2102-2
Org. issuing International ID_1	Wayo Women's University Human Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3390/nu14132579
Number of participants that the trial has enrolled	170
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	Main results already published
Date of protocol fixation	2021 Year 08 Month 18 Day
Date of IRB	2021 Year 09 Month 03 Day
Anticipated trial start date	2021 Year 09 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 06 Month 20 Day

Other
Other related information	This project is a retrospective study using the existing database and an opt-out recruitment method. We release information about this project on the websites of our laboratory and Institute of Community Life Sciences Co., Ltd. to allow declining participation in this study to the candidates.

Management information
Registered date	2021 Year 09 Month 06 Day
Last modified on	2022 Year 09 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051810