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Lipid-lowering Effect of Plant Stanol Yogurt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882517
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Raisio Group

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 20, 2013
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Change in serum LDL cholesterol [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipid-lowering Effect of Plant Stanol Yogurt
Official Title  ICMJE The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Hyperlipidemias
  • Dyslipidemias
Intervention  ICMJE
  • Dietary Supplement: Yogurt that contains plant stanol esters
  • Dietary Supplement: Placebo yogurt
Study Arms  ICMJE
  • Active Comparator: Yogurt that contains plant stanol esters
    Dietary Supplement: Yogurt that contains plant stanol esters
    Intervention: Dietary Supplement: Yogurt that contains plant stanol esters
  • Placebo Comparator: Placebo yogurt
    Dietary Supplement: Placebo yogurt
    Intervention: Dietary Supplement: Placebo yogurt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01882517
Other Study ID Numbers  ICMJE PCL_2010_024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raisio Group
Study Sponsor  ICMJE Raisio Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Raisio Group
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP