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

NCT01461798 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-10-28

No results posted yet for this study

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.

Conditions

  • Risk Reduction Behavior

Interventions

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

Sponsors & Collaborators

  • Jose María Maya Mejía

    lead OTHER

Principal Investigators

  • Johanna Romero, BML · CES University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461798 on ClinicalTrials.gov