Back to resultsLipid-lowering Effect of Plant Stanol Yogurt
Primary Purpose
Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yogurt that contains plant stanol esters
Placebo yogurt
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Yogurt that contains plant stanol esters
Placebo yogurt
Arm Description
Dietary Supplement: Yogurt that contains plant stanol esters
Dietary Supplement: Placebo yogurt
Outcomes
Primary Outcome Measures
Change in serum LDL cholesterol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01882517
Brief Title
Lipid-lowering Effect of Plant Stanol Yogurt
Official Title
The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raisio Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yogurt that contains plant stanol esters
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Yogurt that contains plant stanol esters
Arm Title
Placebo yogurt
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo yogurt
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt that contains plant stanol esters
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo yogurt
Primary Outcome Measure Information:
Title
Change in serum LDL cholesterol
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Lipid-lowering Effect of Plant Stanol Yogurt
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