hypercholestemia
Conditions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject with total cholesterol plasma level of under 240 mg/dL (6.2 mmg/dL) (with half of the subjects at entry under 200 mg/dL or 5.2 mmol/L) 2)Subject with LDL-cholesterol plasma level of under 160 mg/dL (4.1 mmol/L) (with half of the subjects at entry under 120 mg/dL or 3.1 mmol/L) 3)Subject, aged from 20 to 65 years (bounds included) 4)Subject, BMI from 19 to 30 kg/m2 (bounds included) 5)Subject with triglycerides under 400 mg/dL (4.6 mmol/L) 6)Non diabetic subjects (FBS&#8804;125 mg/dL) 7)Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg) 8)Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subjects (according to Japan Atherosclerosis Society guidelines) 9)Subject agreeing not to consume any supplements/excessive plant sterols in any form during the study period (from initial to final visit) 10)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 a clinical trial. 2)Subject taking any hypocholesterolemic treatment drugs (statins,ezetimibe, niacin, omega-3 fatty acids, 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 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 to plant sterols or dairy products. 7)Subjects having lactose intorelance 8) Subjects having sitosterolemia 9)Diabetic subject (Type I and type II) 10)Subject having lactose intolerance. 11)Subject with heavy alcohol intake (> 60g/day) 12)Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 13)Subject receiving a transplant or under immunosuppressor treatment 14)Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 15)Subject deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bloodchemistry, hematology and physical examination after 2-week and 4-week consumption | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. Department of Clinical Evaluation System
Outcome results
None listed