UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020429 |
|---|---|
| Receipt number | R000023593 |
| Scientific Title | Exploratory clinical trial of blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation) in healthy men and women |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2016/05/13 16:37:31 |
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Basic information
Public title
Exploratory clinical trial of blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation) in healthy men and women
Acronym
Exploratory clinical trial of blood CoQ10 concentration after ingestion of reduced form CoQ10 (self- emulsifying formulation)
Scientific Title
Exploratory clinical trial of blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation) in healthy men and women
Scientific Title:Acronym
Exploratory clinical trial of blood CoQ10 concentration after ingestion of reduced form CoQ10 (self- emulsifying formulation)
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate effects on bioavailability of reduced form CoQ10 (self- emulsifying formulation)
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood CoQ10 concentration after one-week ingestion of reduced form CoQ10 (self- emulsifying formulation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of reduced form CoQ10 (self- emulsifying formulation) consecutively for one week
wash out period
Ingestion of reduced form CoQ10
(slurry formulation) consecutively for one week
Interventions/Control_2
Ingestion of reduced form CoQ10
(slurry formulation) consecutively for one week
wash out period
Ingestion of reduced form CoQ10 (self- emulsifying formulation) consecutively for one week
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females aged 40 to 60 years
2)BMI >=18.5 kg/m2 and <25kg/m2
Key exclusion criteria
1)Subjects who previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder.
2)Subjects who are taking medicine or being treated by a doctor
3)Subjects who are intend to undergo treatment or medication by a doctor during the test period.
4)Subjects who has a soy allergy
5)Subjects who smoke present or have smoked within the last one year prior to the current study
6)Subjects who use specified healthy food, functionality food, supplement.
7)Subjects who are intend to use specified healthy food, functionality food, supplement during the test period.
8)Subjects who perform high exercise intensity with fatigue the next day or sunburn.
9)Women who are pregnant or may be pregnant
10)Women who are breast-feeding
11)Subjects who are planning to participate in other clinical study
12)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Orimo |
Organization
Kenkoin Clinic
Division name
Director
Zip code
Address
6-7-4Ginza, Chuo-ku, Tokyo,104-0061
TEL
03-3573-1153
hajime-orimo@kenkoin.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Tsubokawa |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
Kenkoin Clinic
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
Address
Tel
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
| 2016 | Year | 01 | Month | 05 | 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
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2016 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023593
