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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by CES University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Jose María Maya Mejía, CES University
ClinicalTrials.gov Identifier:
NCT01461798
First received: October 20, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Risk Reduction Behavior
Dietary Supplement: assessment of efficacy of Benecol yogurt
Dietary Supplement: Placebo Yogurt
Dietary Supplement: yogurt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011

Resource links provided by NLM:


Further study details as provided by CES University:

Primary Outcome Measures:
  • Benecol Efficacy [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461798

Contacts
Contact: Johanna Romero Palacio, Microbiologa 300788362 jrp922@gmail.com
Contact: Elsa María Vásquez Trespalacios, Epidemióloga 4440555 evasquez@ces.edu.co

Sponsors and Collaborators
Jose María Maya Mejía
Investigators
Principal Investigator: Johanna Romero, BML CES University
  More Information

Publications:
Responsible Party: Jose María Maya Mejía, Johanna Romero Palacio, CES University
ClinicalTrials.gov Identifier: NCT01461798     History of Changes
Other Study ID Numbers: Ben2011
Study First Received: October 20, 2011
Last Updated: October 26, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:
plant stanols
lipids
cardiovascular disease

ClinicalTrials.gov processed this record on August 18, 2014