Lipid-lowering Effect of Plant Stanol Yogurt

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882517
• Other study ID #: PCL_2010_024
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: June 18, 2013
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2013
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Yogurt that contains plant stanol esters

• Placebo yogurt

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Raisio Group

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum LDL cholesterol		4 weeks	No