UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035493 |
|---|---|
| Receipt number | R000040441 |
| Scientific Title | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation) - a randomized, double-blind, parallel study - |
| Date of disclosure of the study information | 2019/11/29 |
| Last modified on | 2019/10/30 09:49:35 |
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Basic information
Public title
Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
- a randomized, double-blind, parallel study -
Acronym
Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
Scientific Title
Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
- a randomized, double-blind, parallel study -
Scientific Title:Acronym
Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the supplement (astaxanthin and lutein containing food, self- emulsifying formulation) on bioavailability
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood astaxanthin and lutein concentration change by 3 consecutive weeks ingestion of test food
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food for 3 consecutive weeks
Interventions/Control_2
Ingestion of control food for 3 consecutive weeks
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged from 20 to 50 years old
2) Subjects whose BMI >=18.5 kg/m2 and <25kg/m2
Key exclusion criteria
1)Subjects who previous serious disease
2)Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy)
3)Subjects who have various symptoms of indigestion (diarrhea, stomach feels upset etc.)
4)Subjects who have the habit of skipping breakfast (meals including staple food)
5)Subjects who smoke present or have smoked within the last one year prior to the current study
6)Subjects who have excessive drinking habits
7)Subjects who are taking medicine, being treated by a doctor or are intend to under medication by a doctor during the test period(hay fever etc)
8) Subjects who routinely take medicine or health foods (supplement containing astaxanthin, lutein, other carotenoids, kale juice etc.) that may affect the results of this study
9) Subjects who intend to become pregnant or lactating
10) Subjects who are judged as unsuitable by doctor for other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yui |
| Middle name | |
| Last name | Kei |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3532
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Naito |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
104-0061
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Kenkoin Medical Corporation Foundation
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel
03-3573-1153
isamu-yanase@kenkoin.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
医療法人財団健康院 健康院クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 29 | 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
| 2018 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040441
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
