Effect of Daily Ingestion of the Scallop Oil on Lipid Metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000037220
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
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 who have a history of cerebrovascular disease. 5. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes. 6. Subjects with familial hypercholesterolemia. 7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 8. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 9. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 10. Subjects with severe anemia. 11. Pre- or post-menopausal women complaining of obvious physical changes. 12. Subjects who are at risk of having allergic reactions to drugs or foods especially based on fish, gelatin, egg, wheat, soybean, chicken and/or pork. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism and blood flow. 14. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 16. 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. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TG after 4, 8 and 12 weeks of ingestion.
- Secondary Outcome Measures
Name Time Method TC, LDL-C, HDL-C, LDL/HDL ratio, non-HDL, phospholipid, BW, BFP, BMI, MDA-LDL, prothrombin time, serum total fatty acid composition, erythrocyte phospholipid fatty acid composition, VAS questionnaire assessed physical condition, Pittsburgh sleep quality index, peripheral blood circulation (estimated age of blood vessel, blood pressure, blood loss, arterial elasticity)