UMIN-CTR Clinical Trial

Basic information
Public title	Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Acronym	Effect of single intake of two different types of fish oil supplements on pharmacokinetics.
Scientific Title	Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Scientific Title:Acronym	Effect of single intake of two different types of fish oil supplements on pharmacokinetics.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of single intake of two different types of fish oil supplements on pharmacokinetics.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the blood concentration-time curve of delta-DHA.
Key secondary outcomes	Area under the blood concentration-time curve of DHA. Area under the blood concentration-time curve of EPA, delta-EPA. Blood concentration of DHA and EPA at each time point after ingestion of the test food. Cmax,Tmax of DHA or EPA.

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	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food (single ingestion) - washout period - intake of control food (single ingestion).
Interventions/Control_2	Intake of control food (single ingestion) - washout period - intake of test food (single ingestion).
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 and Female
Key inclusion criteria	1. Age: 20 -65 years old 2. Sex : Male or Female 3. BMI:18.5 -25.0 kg/m2
Key exclusion criteria	1. Patient with dyslipidaemia. 2. Subjects with severe liver diseases, digestive organ diseases, kidney diseases and heart diseases. 3. Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy). 4. Subjects who have various symptoms of indigestion (diarrhea, stomach feels upset etc.). 5. Subjects who are bleeding at present or danger of bleeding (serious injuries and operations, etc.) 6. Can't stop to take a supplement or medicine including DHA, EPA during the study period. 7. Difficulty in collecting blood. 8. Smoker 9. Subjects who are planned to participate in other clinical study. 10. Subjects who intend to become pregnant or lactating. 11. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	16

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, Japan
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Mariko Middle name Last name Hayashida
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3667
Homepage URL
Email	mariko1512@fancl.co.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	Clinical Research Ethics Committee of FANCL Corporation
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel	045-820-3657
Email	akihide_nisihara@fancl.co.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	株式会社ファンケル 総合研究所（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 12 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	2021 Year 04 Month 30 Day
Date of IRB	2021 Year 05 Month 11 Day
Anticipated trial start date	2021 Year 05 Month 12 Day
Last follow-up date	2021 Year 06 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	2021 Year 05 Month 12 Day
Last modified on	2021 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050425