UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043690 |
|---|---|
| Receipt number | R000049888 |
| Scientific Title | Human clinical study on plasma coenzyme Q10 concentrations |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2021/03/21 16:38:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Human clinical study on plasma coenzyme Q10 concentrations
Acronym
Human clinical study on plasma coenzyme Q10 concentrations
Scientific Title
Human clinical study on plasma coenzyme Q10 concentrations
Scientific Title:Acronym
Human clinical study on plasma coenzyme Q10 concentrations
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of diet on plasma CoQ10 concentrations
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CoQ10 levels
Key secondary outcomes
CoQ10 levels in various areas
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy male and female aged of 20 to 60 years.
2.Subjects who agreed to participate in the study in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study.
Key exclusion criteria
1.Subjects taking supplements containing CoQ10 3 months prior to the study.
2.Subjects who receiving drug treatment.
3.Subjects who participating in any other clinical study/trial or within 4 weeks after participating in another study.
4.Subjects who have history of present illness and past medical history that affect digestion and absorption of diet.
5.Subjects who cannot eat orally.
6.Subjects who are in pregnant, breast feeding, or expect to be pregnant during the study.
7.Subject who have smoking habits.
8.Subjects who continue high-intensity exercise regularly.
9.Subjects judged inappropriate for this study by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Funahashi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
5308288
Address
2-3-18, Nakanoshima, Kita-ku, Osaka
TEL
06-6226-5050
Iwao.Funahashi@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Yamaguchi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
5308288
Address
2-3-18, Nakanoshima, Kita-ku, Osaka
TEL
050-3133-7356
Homepage URL
Takao.Yamaguchi@kaneka.co.jp
Sponsor or person
Institute
KANEKA CORPORATION
Institute
Department
Personal name
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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
info@miura-cl.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 | 02 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049888
