UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial on serum DHA concentration by consecutive ingestion of self-emulsifying formulation or nonself-emulsifying formulation contained DHA. A randomized, double-blind, crossover study.
Acronym	Clinical trial on serum DHA concentration by consecutive ingestion of self-emulsifying formulation or nonself-emulsifying formulation contained DHA.
Scientific Title	Clinical trial on serum DHA concentration by consecutive ingestion of self-emulsifying formulation or nonself-emulsifying formulation contained DHA. A randomized, double-blind, crossover study.
Scientific Title:Acronym	Clinical trial on serum DHA concentration by consecutive ingestion of self-emulsifying formulation or nonself-emulsifying formulation contained DHA.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of difference in the absorption by a treatment of self-emulsification formulation contained DHA.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum DHA concentration Before 1 week, 0 week, 1week, 2weeks
Key secondary outcomes	Serum EPA concentration Before 1 week, 0 week, 1week, 2weeks

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 2 weeks
Interventions/Control_2	Ingestion of control food for 2 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	65 years-old >
Gender	Male
Key inclusion criteria	1. Age: 20 -65 years old 2. Sex : Male 3. BMI:18.5-30 kg/m2 4. Written informed consent
Key exclusion criteria	1. Patient with dyslipidaemia 2. Medical treatment for some diseases 3. Subjects with severe liver diseases, digestive organ diseases, kidney diseases and heart diseases 4. Sublects who are bleeding at present or danger of bleeding (serious injuries and operations, etc.) 5. Can't stop to take a supplement during the study period. 6. Difficulty in collecting blood. 7. Smoker 8. Subjects who are planned to participate in other clinical study. 9. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	60

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
TEL	045-820-3755
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

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 08 Month 01 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	2019 Year 07 Month 16 Day
Date of IRB	2019 Year 07 Month 16 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 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 07 Month 31 Day
Last modified on	2020 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042822