A study on the Cholesterol Reduction Effects of Krill Oil Intake - Double-blind, Placebo-Controlled, Randomized, Parallel Group Comparison Trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000053014
- Lead Sponsor
- TRIONE CO.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
1.have had medical treatment for any disease or have been on any other drugs and Kampo medicines in the past 6 months. 2.have a current or past history of clinically significant acute or chronic diseases requiring acute or chronic treatment in various body systems including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic and tumoral, and gastrointestinal diseases, or systemic infectious diseases. 3.have undergone antipsychotic drug treatment in the past 3 months. 4.Those undergoing diet or exercise therapy under the supervision of a physician. 5.current or past history of serious diseases other than those mentioned in 2. 6.currently taking medicines, quasi-drugs, FOSHU, FFC, health foods, or supplements that may affect weight, blood triglycerides, or cholesterol levels. 7.currently taking drugs or foods other than those mentioned in 6, at least three times a week. However, those who can stop taking them after obtaining consent can participate. 8.AST or ALT levels more than three times the upper limit of the standard at visit 1. 9.serum creatinine levels of 2.0mg/dL or more at visit 1. 10.have a current or past history of drug or food allergies. 11.have a past history of significant hypersensitivity to krill oil components. 12.planning to make major changes to their lifestyle habits during the trial period. 13.planning to travel overseas during the trial period. 14.pregnant, lactating, or wishing to become pregnant during the trial period. 15.shift workers. 16.have a past history of alcohol addiction or drug abuse. 17.heavy drinkers (40g or more of alcohol/day). 18.heavy smokers (more than 21 cigarettes/day). 19.have participated in other clinical trials within one month prior to obtaining consent, are currently participating, or plan to participate during the trial period. 20.Those deemed unsuitable for participation in this study by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-C, T-Cho
- Secondary Outcome Measures
Name Time Method TG, HDL-C, Non-HDL-C, NEFA, Apolipoprotein A1, Apolipoprotein B, atherosclerosis index, Body weight, BMI, Blood fatty acids