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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

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

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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

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882517


Locations
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Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Raisio Group
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Responsible Party: Raisio Group
ClinicalTrials.gov Identifier: NCT01882517    
Other Study ID Numbers: PCL_2010_024
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases