NCT02644109

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols In Chilean Subjects With Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Different protocols have demonstrated that phytosterol intake fluctuates between 1000 to 2000 mg per day decreasing LDL by around 10%, independently of levels of blood triglycerides and HDL (high density lipoproteins) concentrations. In fact, the National Cholesterol Education Program and the American Heart Association recommend the addition of 2 g/day of phytosterols to daily diet of adults. This is also recommended by the FDA (Food and Drug administration). Phytosterols delivery has been proven effective when administrated in lipid matrixes such as margarines and dressings and low-fat such as skimmed milk and yogurt, proving to have an hypolipidemic effect. The investigational products consist of powder milk and a drinking yoghurt with the addition of esterified phytosterols, with a total daily intake of 1.95 g/day (1.17 g/day of free equivalent). Primary objective: To evaluate the impact in Chilean population of phytosterols incorporated into dairy products in reduction of LDL cholesterol. Secondary objectives: 1. To evaluate potential changes in blood cholesterol concentration according to nutritional state and age. 2. To determine the appearance of symptoms and/or effects during the intervention period. The trial has been designed to evaluate the effect of phytosterols incorporated to low fat dairy products in Chile, through the consumption of one glass of milk powder and 90 mL of drinking yoghurt, which results in a daily consumption of 1.95 g/day of esterified phytosterols. This amount falls within demonstrated effective doses reported in literature.

Conditions

• Dyslipidemias
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Phytosterol	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.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-12-31
• Last updated: 2016-09-12
• Results posted: 2016-08-02

Locations

2 sites across 1 country: Chile