Healthy adults
Conditions
Interventions
Participants will take one capsule of the control food twice daily, after breakfast and dinner, with water or warm water.
Participants will also take one capsule of the test food twice daily, after br
Sponsors
NUTRIONE CO.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: Between 20 and 75 2. Gender: Japanese men and women 3. LDL-C levels of 120mg/dL or more but less than 180mg/dL and T-Cho levels of 200mg/dL or more at SCR (Visit 1) 4. Capability of inputting electronic diary via smartphone or PC 5. Individuals who have been given a comprehensive explanation about the purpose and content of the study, fully understand it, voluntarily agree to participate, and provide written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C, T-Cho | — |
Secondary
| Measure | Time frame |
|---|---|
| TG, HDL-C, Non-HDL-C, NEFA, Apolipoprotein A1, Apolipoprotein B, atherosclerosis index, Body weight, BMI, Blood fatty acids | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed