hypercholestemia
Conditions
Interventions
Effectiveness and safety after 12 weeks of test food consumption compared to before comsumption
Effectiveness and safety of 12-week test food consumption compared to placebo control
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject with total cholesterol serum level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL 2) Subject, aged from 20 to 65 years (bounds included) 3) Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subject taking any hypocholesterolemic treatment 2) Subfect currently involved in other clinical trial 3) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study 4) For female subject: pregnancy or possibility of pregnancy, or intention to be pregnant during the study 5) For female subject: breast feeding 6) Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products 7) Subject having sitosterolemia 8) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders 9) Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bloodchemisty, hematology and physical examination at 4-week, 8-week, 12-week consumption and 4-week after consumption period | — |
Countries
Japan
Outcome results
None listed