Status:
COMPLETED
Lipid-lowering Effect of Plant Stanol Yogurt
Lead Sponsor:
Raisio Group
Conditions:
Hypercholesterolemia
Hyperlipidemias
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
To determine the effect of investigational products on serum LDL cholesterol.
Detailed Description
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 monitor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01882517
Start Date
March 1 2011
End Date
January 1 2012
Last Update
June 20 2013
Active Locations (1)
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1
Hacettepe University
Ankara, Turkey (Türkiye)