Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols
Condition: Dyslipidemias; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Phytosterol; Placebo
Intervention description: Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.
Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged.; Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.
Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated
      primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous
      hepatic synthesis of cholesterol and its absorption at intestinal level. It has been
      demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins,
      which are the first treatment option for a moderate hypercholesterolemia.

      Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation
      into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment
      against low hypercholesterolemia. The target population are 40 to 65 years old individuals
      with low hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals between 40 to 65 y old.

          2. Males and females.

          3. Body mass index between 20 to 35 kg/m2

          4. Mild hypercholesterolemia (LDL between 130 to 190 mg/dl) without requirement of
             immediate pharmacological treatment.

          5. Without symptoms of atherosclerotic vascular disease.

          6. Regular consumption of dairy foods (at least once a day).

          7. Sedentary lifestyle defined as less than 20 min, three times per week of moderate to
             intense physical activity)

        Exclusion Criteria:

          1. Individuals with sitosterolemia.

          2. Use of hypolipidemic drugs within the past 6 weeks before initiated the study.

          3. Presence of type 1 or 2 diabetes; nephrotic syndrome or chronic kidney disease at
             stage III (estimated glomerular filtration rate<60 ml/min) or higher;
             gastrointestinal, liver, hepatobiliary, endocrine diseases or any condition
             potentially effecting lipid metabolism.

          4. History of heart failure, unstable angina, cerebrovascular accident, heart failure,
             uncontrolled arrhythmias, high blood pressure (systolic>160 mm/Hg or diastolic>100
             mm/Hg), cardiac surgery or other vascularization procedure.

          5. Blood triglycerides higher than 400 mg/dl.

          6. History of cancer disease over the last 5 years.

          7. Pregnant and lactating women.

          8. Lactose intolerant individuals or presence of related symptoms

          9. Individuals with cow´s milk protein allergy.

         10. Vegetarians

         11. Regular use of drugs for obesity treatment, or affecting lipid metabolism.

         12. Regular use of nutritional supplements.

         13. Smokers having more than 5 units per day.

         14. Individuals drinking more than 3 standard units per day of alcoholic beverages (>3
             glasses of wine, 2 beers o 1 strong alcohol).