Lipid-lowering Effect of Plant Stanol Yogurt

NCT ID: NCT01882517

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-01-31

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

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Yogurt that contains plant stanol esters

Dietary Supplement: Yogurt that contains plant stanol esters

Group Type: ACTIVE_COMPARATOR

Yogurt that contains plant stanol esters

Intervention Type: DIETARY_SUPPLEMENT

Placebo yogurt

Dietary Supplement: Placebo yogurt

Group Type: PLACEBO_COMPARATOR

Placebo yogurt

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Yogurt that contains plant stanol esters

Intervention Type: DIETARY_SUPPLEMENT

Placebo yogurt

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Raisio Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PCL_2010_024

Identifier Type: -

Identifier Source: org_study_id