UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050936 |
|---|---|
| Receipt number | R000058057 |
| Scientific Title | Changes in serum Coenzyme Q10 (CoQ10) levels by diet and CoQ10-fortified foods |
| Date of disclosure of the study information | 2023/04/26 |
| Last modified on | 2024/07/03 18:39:39 |
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Basic information
Public title
Changes in blood Coenzyme Q10 (CoQ10) levels by diet and CoQ10-fortified foods
Acronym
Changes in blood CoQ10 levels by diet
Scientific Title
Changes in serum Coenzyme Q10 (CoQ10) levels by diet and CoQ10-fortified foods
Scientific Title:Acronym
Changes in serum CoQ10 levels by diet
Region
| Japan |
Condition
Condition
NOthing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference in food intake and the degree of fluctuation in serum CoQ10 levels caused by the intake of CoQ10-fortified foods.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between diet and serum CoQ10 levels
Key secondary outcomes
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
Female
Key inclusion criteria
Twenty-two people participated in the "Investigation of functional foods on blood coenzyme Q10 (CoQ10) levels and variation by single nucleotide polymorphism," which was approved by the Wayo Women's University Human Research Ethics Committee (No. 1513) and held from 2015 to 2016.
Key exclusion criteria
Nothing
Target sample size
22
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
2-3-1 Konodai, 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
https://wayonutrsuzukilab.wixsite.com/biochem
t-suzuki@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Toshikazu Suzuki
Funding Source
Organization
Wayo Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
和洋女子大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2674-0311/3/3/18
Number of participants that the trial has enrolled
22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 03 | Day |
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
| 2023 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 04 | Month | 28 | Day |
Other
Other related information
To examine associations between diet and serum CoQ10 levels using previous intervention trial data.
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058057
