UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046028 |
|---|---|
| Receipt number | R000052537 |
| Scientific Title | Effect of single intake of different emulsified types of CoQ10 supplements on pharmacokinetics in adults. -A randomized, double-blinded, Latin-square study- |
| Date of disclosure of the study information | 2021/11/10 |
| Last modified on | 2022/05/10 14:34:07 |
* 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
Effect of single intake of different emulsified types of CoQ10 supplements on pharmacokinetics in adults. -A randomized, double-blinded, Latin-square study-
Acronym
Effect of single intake of different emulsified types of CoQ10 supplements on pharmacokinetics in adults.
Scientific Title
Effect of single intake of different emulsified types of CoQ10 supplements on pharmacokinetics in adults. -A randomized, double-blinded, Latin-square study-
Scientific Title:Acronym
Effect of single intake of different emulsified types of CoQ10 supplements on pharmacokinetics in adults.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of single intake of different emulsified type CoQ10 supplements on pharmacokinetics.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the blood concentration-time curve of delta-CoQ10.
Key secondary outcomes
Area under the blood concentration-time curve of CoQ10.
Blood concentration of CoQ10 at each time point after ingestion of the test food.
Cmax,Tmax of CoQ10.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 (single ingestion) - washout period - intake of test food 3 (single ingestion). - washout period - intake of test food 2 (single ingestion).
Interventions/Control_2
Intake of test food 3 (single ingestion) - washout period - intake of test food 2 (single ingestion). - washout period - intake of test food 1 (single ingestion).
Interventions/Control_3
Intake of test food 2 (single ingestion) - washout period - intake of test food 1 (single ingestion). - washout period - intake of test food 3 (single ingestion).
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. Age: 20 -60 years old healthy Male or Female
2. BMI:18.5 -25.0 kg/m2
Key exclusion criteria
1. Subjects who are undergoing medication treatment, excluding the use of antipyretic analgesics
2. Subjects who cannot stop taking specified healthy food, functionality food, supplement, or foods with CoQ10 added during the study period
3. Subjects who have soy allergy
4. Subjects who is a current smoker or have smoked within the last one year prior to the present study
5. Women who are pregnant or may be pregnant
6. Women who are breast-feeding
7. Subjects who have difficulty when collecting blood samples
8. Subjects who are planning to participate in other clinical study during the present study
9. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hayashida |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3667
Homepage URL
mariko1512@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Clinical Research Ethics Committee of FANCL Corporation
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel
045-820-3657
akihide_nisihara@fancl.co.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
株式会社ファンケル 総合研究所（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052537
