Lipid-lowering Effect of Plant Stanol Yogurt

Launched by RAISIO GROUP · Jun 18, 2013

Keywords

ClinConnect Summary

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.

Study was monitored by Foodfiles

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • subjects must voluntarily sign the informed consent
• • subjects must be male or female aged 20 to 70 years
• • subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)
• Exclusion Criteria:
• • subjects using lipid lowering medication
• • subjects using ezetimibe
• • subjects with bile acid sequestrant medication
• • subjects with statin therapy
• • subjects using other medication significantly influencing on lipid values
• • subjects with diagnosis type 1 or type 2 diabetes
• • severe obesity (BMI\>35.0 kg/m2)
• • serum fasting triglycerides \> 4.0 mmol/l
• • subjects with any hepatic or renal disorder according to medical history
• • subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
• • subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
• • subjects who have history of temporal ischemic attack or stroke within six months prior to screening
• • subjects who have a history of cancer or other malignant disease within the past five years
• • subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase\> 2 x upper limit, serum alkaline phosphatase\> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
• • subjects who are consuming more than 15 portions of alcohol / week
• • subjects who are pregnant or lactating
• • subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2
• • subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products
• • celiac disease