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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044188
Receipt No. R000050425
Scientific Title Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Date of disclosure of the study information 2021/05/12
Last modified on 2021/11/29

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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

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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