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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037558
Receipt No. R000042822
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.
Date of disclosure of the study information 2019/08/01
Last modified on 2019/08/10

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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 No longer recruiting
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 10 Month 31 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
2019 Year 08 Month 10 Day


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

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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