Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2. Healthy subjects.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly take anticoagulant, antiplatelet medicine, and/or NSAIDs. 2. Subjects who take ethyl icosapentate. 3. Subjects with blood coagulation disorders. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on fish and/or gelatin. 10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 12. Pregnant or lactating women or women who expect to be pregnant during this study. 13. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 14. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of side effects related to ingestion of the test food during the ingestion period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of adverse events, BW, BFP, BMI, BP, heart rate, body temperature, hematological test (WBC, RBC, Hb, Ht, and Plt), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, phospholipid, FBG, HbA1c, TP, Alb, A/G ratio, CPK, Na, Cl, K, Ca, Mg, P, neutrophils, lymphocytes, monocytes, eosinophils, basophils), serum total fatty acid composition, erythrocyte phospholipid fatty acid composition and urine analysis (pH, protein, sugar, urobilinogen, ketone bodies and occult blood). | — |
Countries
Japan
Contacts
Hokkaido Information University Health Information Science Center