NCT01461798

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jose María Maya Mejía · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Introduction: 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.

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.

Conditions

• Risk Reduction Behavior

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Placebo Yogurt	Yogurt without the active principle
DIETARY_SUPPLEMENT	yogurt	yogurt without plant stanols

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2011-10-28
• Last updated: 2011-10-28