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Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011 (Ben2011)

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. Identifier: NCT01461798
Recruitment Status : Unknown
Verified October 2011 by Jose María Maya Mejía, CES University.
Recruitment status was:  Not yet recruiting
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
Jose María Maya Mejía, CES University

Brief Summary:


Cardiovascular diseases have become the leading cause of death from chronic diseases in the world. One of the major risk factors for this disease is hypercholesterolemia, caused in most cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is plant stanol ester that competes with total cholesterol and low density lipoprotein or LDL cholesterol by preventing them to be absorbed by the body and reducing blood levels.

Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.

Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES control clinic in Medellin.

Expected results: Test the effectiveness of plant stanol esters in reducing total cholesterol and LDL cholesterol in patients with moderate hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Risk Reduction Behavior Dietary Supplement: assessment of efficacy of Benecol yogurt Dietary Supplement: Placebo Yogurt Dietary Supplement: yogurt Not Applicable

Detailed Description:

The main cause of death worldwide are cardiovascular diseases, generated mainly by disturbances in the lipid profile. Several studies have shown that dyslipidemia is an important risk factor for this condition, thus maintaining the level of lipids in an appropriate range is ideal for preventing cardiovascular diseases (1)

Cardiovascular diseases are a serious epidemiological problem in the contemporary world, with approximately 17 million people die each year from causes such as myocardial infarction and stroke. The increase in cardiovascular disease and mortality attributable to them is a topic widely reported by several authors in the world. In Colombia after death from violent causes, cardiovascular diseases are on the second of the five leading causes of mortality in the general population.

Having high total cholesterol is a risk factor for the occurrence of various diseases of the circulatory system, therefore it is important to keep total cholesterol below 200 mg / dl and LDL cholesterol levels under 150 mg/dl, to avoid the accumulation of fat within the walls of the arteries that can lead to the formation of atherosclerotic plaques that cause decreased blood flow

The atlas published by WHO in 2005 provides comprehensive data on morbidity and mortality attributable to noncommunicable diseases, which are increasing. It is estimated that in 2001 approximately 60% of the 56.5 million deaths worldwide and 46% of diseases are due to noncommunicable diseases. The epidemiological burden of these diseases will increase to 57% by the year 2020. Almost 50% of deaths due to noncommunicable diseases are due to cardiovascular disease. By 2020, these diseases are responsible for 75% of all deaths worldwide.

Given the high prevalence of cardiovascular disease and dyslipidemia are considered a high risk factor for these occur, it is necessary to test the effectiveness of including the consumption of plant stanol esters in the diet to lower cholesterol values Total and LDL Cholesterol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011
Study Start Date : October 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Benecol
In 2009, the dairy Cooperative Colanta Launches Benecol ® yogurt, a product with optimal daily dose of plant stanol, each portion of 100 g containing 3.4 g of Benecol ®, corresponding to 2 g of plant stanol esters . Skim yogurt with Benecol ® is a product made from pasteurized skim milk, sweetened with sucralose homogenized and fermented by the action of specific lactic culture to obtain the optimal characteristics of texture and acidity. With the addition of fruit pulp and supplemented with plant stanol esters (Benecol ®) to help reduce the risk of cardiovascular disease (31). According to Weiss et al, drinkable yogurt with Benecol ® reduces total cholesterol by 5.8% and 9.8% in LDL cholesterol (32).
Dietary Supplement: assessment of efficacy of Benecol yogurt
Benecol Yogurt and Yogurt placebo for 4 weeks each, at a dose of 100 ml (200 ml in total) of yogurt twice a day with main meals
Other Names:
  • Benecol Yogurt
  • Placebo Yogurt

Dietary Supplement: Placebo Yogurt
Yogurt without the active principle
Other Name: Colanta Yogurt

Placebo Comparator: yogurt
Yogurt without plant stanols
Dietary Supplement: yogurt
yogurt without plant stanols
Other Name: Yogurt Colanta

Primary Outcome Measures :
  1. Benecol Efficacy [ Time Frame: 9 weeks ]
    Week 1: it will be taken a blood sample for lipid profile and other tests of liver and kidney function, patients will begin the Benecol ® yogurt consumption or placebo for four weeks, at week 5 it will be taken a new blood sample to perform mentioned test lipid levels and meet and determine the changes presented, patients will have a wash out week in Week 6 and groups will change for four weeks, at the end of week 9 will be held the last shot of sample for all tests again

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sign voluntarily the informed consent
  • Male or female 20 to 50 years
  • The concentration of total serum cholesterol of 5.2 - 7.5 mmol / l (205-290 mg / dl) at the screening visit (Visit 1 to 2 week)

Exclusion Criteria:

  • Lipid-lowering medication or other drugs that significantly affect lipid values
  • Diabetes Type I or II
  • Severe obesity (BMI greater than 35 kg/m2)
  • Fasting serum triglycerides> 4.0 mmol / l
  • Liver or kidney disorder according to medical history
  • History of coronary revascularization percutaneous transluminal coronary angioplasty within six months prior to screening
  • History of temporary ischemic attack or stroke within six months prior to screening
  • History of cancer or other malignant disease in the last five years
  • Consumption of more than 15 parts of alcohol/week
  • Pregnant or lactating
  • Benecol consumption in your diet, or other plant sterol enriched products 30 days before visit 2 (Week 1), these will be identified by the survey
  • Severe lactose intolerance, milk allergy or any other form of intolerance to the ingredients of the 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 identifier (NCT number): NCT01461798

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Contact: Johanna Romero Palacio, Microbiologa 300788362
Contact: Elsa María Vásquez Trespalacios, Epidemióloga 4440555

Sponsors and Collaborators
Jose María Maya Mejía
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Principal Investigator: Johanna Romero, BML CES University
Publications of Results:
Other Publications:
Furgione A y col. Dislipidemias primarias como factor de riesgo para enfermedad coronaria.Revista latinoamericana de hipertensión. 2009;4(1)
Katan et al. El efecto del éster estanol vegetal. Revista Europea de Nurición Clínica. 2009;63:2-10
Musa-Veloso K et al. Una comparación entre la eficacia para disminuir el colesterol - LDL de los estanoles vegetales y los esteroles vegetales dentro de un rango de dosis continúo: Resultados de un meta-análisis de estudios controlados randomizados con placebo. 2011

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jose María Maya Mejía, Johanna Romero Palacio, CES University Identifier: NCT01461798    
Other Study ID Numbers: Ben2011
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011
Keywords provided by Jose María Maya Mejía, CES University:
plant stanols
cardiovascular disease