Lipid-lowering Effect of Plant Stanol Yogurt

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
• Interventions: Dietary Supplement: Yogurt that contains plant stanol esters; Dietary Supplement: Placebo yogurt

• Registration Number: NCT01882517
• Lead Sponsor: Raisio Group

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 monitored by Foodfiles

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Study First Posted: 2013-06-20
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yogurt that contains plant stanol esters	Yogurt that contains plant stanol esters	Dietary Supplement: Yogurt that contains plant stanol esters
Placebo yogurt	Placebo yogurt	Dietary Supplement: Placebo yogurt

Primary Outcome Measures

Name	Time	Method
Change in serum LDL cholesterol	4 weeks

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey