UMIN-CTR Clinical Trial

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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