Status:

UNKNOWN

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

Lead Sponsor:

Jose María Maya Mejía

Conditions:

Risk Reduction Behavior

Eligibility:

All Genders

20-50 years

Phase:

NA

Brief 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...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2012

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01461798

Start Date

October 1 2011

End Date

March 1 2012

Last Update

October 28 2011

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