hypercholestemia
Conditions
Interventions
Effectiveness and safety after 12 weeks of test food consumption compared to before consumption
Effectiveness and safety of 12-week test food consumption compared to placebo control
Effectiveness and
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject with total cholesterol plasma 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 with BMI between 19 - 30 kg/m2; (bounds included) 4) Subject with triglycerides under 400 mg/dL 5) Non diabetic subjects (BS<=125 mg/dL) 6) Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg) 7) Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subjects (according to Japan Atherosclerosis Society guidelines) 8) Subject agreeing not to consume any supplements/excessive plant sterols in any form during the study priod (from initial to final visit) 9) 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 currently involved in other clinical trial. 2) Subject taking any hypocholesterolemic treatment (statins, ezetimibe, niacin, omega-3 FA, fibrates) 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 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 lactose intolerance. 8) Subject having sitosterolemia 9) Diabetic subject (Type I and type II) 10) Subject with heavy alcohol intake (>60 g/day) 11) Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 12) Subject receiving a transplant or under immunosuppressor treatment 13) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 14) Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angor pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months 15) Subject deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bloodchemisty, hematology and physical examination after 4-week, 8-week and 12-week consumption | — |
Countries
Japan
Outcome results
None listed