hypercholestemia
Conditions
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 (with half of the subjects at entry) 2) Subject with total cholesterol serum level under 200 mg/dL, or LDL cholesterol plasma under 120 mg/dL (with half of the subjects at entry) 3) Subject with SBP<160 mmHg and DBP<100 mmHg, BMI from 19 to 30 kg/m2, FBS less or equal 125 mg/dL 4) Subject, aged from 20 to 65 years (bounds included) 5) 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 drugs 2) Subject currently involved in a 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 of 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 7) Subject having sitosterolemia 8) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, of metabolic disorders 9) Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bloodchemistry, hematology and physical examination at 2-week, 4-week consumption and 2-week after consumption period | — |
Countries
Japan
Outcome results
None listed