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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041670
Receipt No. R000047557
Scientific Title Clinical trial on the absorption of triglyceride form of DHA by intake conditions (Pilot Study)-A randomized open label crossover study
Date of disclosure of the study information 2020/09/03
Last modified on 2020/09/03

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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
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 Preinitiation
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
2020 Year 09 Month 03 Day


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

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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