UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041670 |
|---|---|
| Receipt number | 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 | 2021/05/13 11:37:45 |
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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
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
mariko1512@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047557
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
