Lipid-lowering Effect of Plant Stanol Yogurt

The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Yogurt that contains plant stanol esters; Dietary supplement: Placebo yogurt

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yogurt that contains plant stanol esters; Dietary Supplement: Yogurt that contains plant stanol esters	Dietary supplement: Yogurt that contains plant stanol esters
Placebo Comparator: Placebo yogurt; Dietary Supplement: Placebo yogurt	Dietary supplement: Placebo yogurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum LDL cholesterol	4 weeks

Collaborators and Investigators

• Sponsor: Raisio Group

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: PCL_2010_024