Healthy individuals
Conditions
Interventions
Intake of test food for 12 consecutive weeks
Intake of control placebo for 12 consecutive weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 64 years old (2) Participants with LDL cholesterol levels of 120-139 mg/dL or 140-159 mg/dL. However, less than half of the participants should have140-159 mg/dL. (3) Participants who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Exclusion criteria
Exclusion criteria: (1) Participants with a history of hypercholesterolemia, psychiatric disorders, diabetes, liver disease, kidney disease, digestive disorders, cardiac diseases, respiratory diseases, peripheral vascular disorders, or other serious diseases (2) Participants who undergo surgery on the digestive tract (3) Participants with abnormal liver and kidney function tests (4) Participants with diseases currently being treated (5) Participants who are allergic to food and drugs (6) Participants with anemia symptoms (7) Female participants wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female participants (8) Participants who play intense sports and participants who are on a diet (9) Participants with extremely irregular eating habits (10) Participants who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Participants who are continuously receiving treatment with pharmaceuticals (including OTC and prescription drugs) (12) Participants who drink more than 60 g of average daily pure alcohol (13) Participants who smoke an average of 21 or more cigarettes a day (14) Participants who are participating in or will participate in other clinical trials at the start of this study. (15) Other participants judged by the investigator or the investigator to be inappropriate for the examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol HDL cholesterol Total cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxidized LDL cholesterol sd-LDL cholesterol RLP cholesterol non-HDL cholesterol IL-10 | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed