Lipid-lowering Effect of Plant Stanol Yogurt

Raisio Group

Status

Completed

Conditions

Hyperlipidemias

Dyslipidemias

Hypercholesterolemia

Treatments

Dietary Supplement: Yogurt that contains plant stanol esters

Dietary Supplement: Placebo yogurt

Study type

Interventional

Funder types

Industry

Identifiers

NCT01882517

PCL_2010_024

Details and patient eligibility

About

To determine the effect of investigational products on serum LDL cholesterol.

Full 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 monitored by Foodfiles

Enrollment

70 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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