Unique ID issued by UMIN | UMIN000044188 |
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Receipt number | 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 10:44:48 |
Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Effect of single intake of two different types of fish oil supplements on pharmacokinetics.
Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Effect of single intake of two different types of fish oil supplements on pharmacokinetics.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
Investigation of single intake of two different types of fish oil supplements on pharmacokinetics.
Bio-availability
Confirmatory
Area under the blood concentration-time curve of delta-DHA.
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.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
NO
No need to know
2
Treatment
Food |
Intake of test food (single ingestion) - washout period - intake of control food (single ingestion).
Intake of control food (single ingestion) - washout period - intake of test food (single ingestion).
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Age: 20 -65 years old
2. Sex : Male or Female
3. BMI:18.5 -25.0 kg/m2
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.
16
1st name | Kei |
Middle name | |
Last name | Yui |
FANCL Corporation
Research Institute, Health science research center
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3755
ke-yui@fancl.co.jp
1st name | Mariko |
Middle name | |
Last name | Hayashida |
FANCL Corporation
Research Institute, Health science research center
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3667
mariko1512@fancl.co.jp
FANCL Corporation
FANCL Corporation
Profit organization
Clinical Research Ethics Committee of FANCL Corporation
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3657
akihide_nisihara@fancl.co.jp
NO
株式会社ファンケル 総合研究所(神奈川県)
2021 | Year | 05 | Month | 12 | Day |
Unpublished
Completed
2021 | Year | 04 | Month | 30 | Day |
2021 | Year | 05 | Month | 11 | Day |
2021 | Year | 05 | Month | 12 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 05 | Month | 12 | Day |
2021 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050425
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