UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045397 |
|---|---|
| Receipt number | R000051810 |
| 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. |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2022/09/07 09:13:47 |
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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
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
t-suzuki@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051810
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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