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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035493
Receipt No. 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

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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
Email 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
Email reiko-naito@kenkoin.jp

Sponsor
Institute FANCL Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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