UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial on the absorption of triglyceride form of DHA by intake conditions (Pilot Study)-A randomized open label crossover study
Acronym	Study about the difference of triglyceride form of DHA absorption by the effect of food intake.
Scientific Title	Clinical trial on the absorption of triglyceride form of DHA by intake conditions (Pilot Study)-A randomized open label crossover study
Scientific Title:Acronym	Study about the difference of triglyceride form of DHA absorption by the effect of food intake.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the effect of intake conditions (fasting and feeding) on absorption of triglyceride form of DHA preparations
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood DHA concentration
Key secondary outcomes	Blood EPA concentration

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Single ingestion of test food after fasted
Interventions/Control_2	Single ingestion of test food after fed
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 to 65 years old 2. Sex: Male or Female 3. BMI: 18.5 to 25.0 kg/m2 4. Written informed consent
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	30

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	㈱ファンケル（神奈川県）/FANCL Co.

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 03 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	30
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	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 09 Month 09 Day
Last follow-up date	2020 Year 10 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 03 Day
Last modified on	2021 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047557