Lipid-lowering Effect of Plant Stanol Yogurt

• ClinicalTrials.gov Identifier: NCT01882517
• Recruitment Status: Completed
• First Posted: June 20, 2013
• Last Update Posted: June 20, 2013
• Sponsor: Raisio Group
• Information provided by (Responsible Party): Raisio Group

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia; Hyperlipidemias; Dyslipidemias	Dietary Supplement: Yogurt that contains plant stanol esters; Dietary Supplement: Placebo yogurt	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
• Study Start Date: March 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in serum LDL cholesterol [ Time Frame: 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Hacettepe University

Ankara, Turkey

Sponsors and Collaborators

Raisio Group

More Information

• Responsible Party: Raisio Group
• ClinicalTrials.gov Identifier: NCT01882517
• Other Study ID Numbers: PCL_2010_024
• First Posted: June 20, 2013
• Last Update Posted: June 20, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases