At a glance
ClinicalIndex Comparison Record- ✓Age 40 to 65 years
- ✓Mild hypercholesterolemia with LDL between 130 to 190 mg/dL without current need for drug treatment
- ✓No symptoms of atherosclerotic vascular disease
- ✓BMI between 20 to 35 kg/m²
- ✕History of heart failure, unstable angina, cerebrovascular accident, uncontrolled arrhythmias, or cardiac surgery
- ✕Uncontrolled hypertension: systolic >160 mm Hg or diastolic >100 mm Hg
- ✕Use of hypolipidemic drugs within 6 weeks before study initiation
- ✕Type 1 or 2 diabetes, or chronic kidney disease stage III or higher (eGFR <60 mL/min)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols In Chilean Subjects With Hypercholesterolemia
In Brief
A Phase 4 clinical trial evaluating Phytosterol and Placebo for Dyslipidemias and Hypercholesterolemia. Completed, enrolled 52 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.