UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049508 |
|---|---|
| Receipt number | R000056377 |
| Scientific Title | Investigation of genetic individual differences in the health maintenance and promotion effects of reduced CoQ10-containing foods |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2025/05/18 11:35:54 |
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Basic information
Public title
Study of genetic individual differences in the degree of health benefits brought about by Q10 yogurt intake
Acronym
Q10 yogurt health benefits and individual genetic differences
Scientific Title
Investigation of genetic individual differences in the health maintenance and promotion effects of reduced CoQ10-containing foods
Scientific Title:Acronym
Q10 yogurt health benefits and individual genetic differences
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relationship between the health effects of participants in the Q10 yogurt health examination (UMIN000049500) and the SNPs of CoQ10 metabolism-related genes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between cognitive function and SNPs involved in the metabolism of CoQ10
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consuming the food or the supplement containing 100 mg reduced CoQ10.
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 participate Q10 yogurt health examination (UMIN000049500).
(2) Those who can understand the purpose and the contents of this study, and can agree with participation in writing.
Key exclusion criteria
Nothing
Target sample size
300
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
2-3-1 Konodai, Ichikawa, Chiba
TEL
043-371-1547
Homepage URL
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
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
| 2022 | Year | 11 | Month | 18 | 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
253
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
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056377
