Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia
Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia
Background information Studies have been conducted on supplementing the daily diet with plant
 sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and,
 consequently, cardiovascular risk. However, clinical practice guidelines on
 hypercholesterolaemia state that there is not sufficient evidence to recommend their use in
 subjects with hypercholesterolaemia. The null hypothesis establishes that there is no
 relationship between the decrease in blood LDL-cholesterol levels and the consumption of
 stanol ester enriched liquid yoghurt. The alternative hypothesis establishes a relationship
 between such consumption and the incidence of the primary variable.

 The main objective of this study is to determine the efficacy of the intake of 2 g of plant
 sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with
 hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily
 intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and
 cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of
 adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that
 determine a greater reduction in lipid levels in subjects receiving plant sterol ester
 supplements.

 Study design Randomised, double-blind, placebo controlled experimental trial carried out at
 family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The
 study subjects will be adults diagnosed with "limit" or "defined" hypercholesterolaemia and
 who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid
 yoghurt containing 2 g of plant sterol ester per container will be administered daily after
 the main meal, for a period of 24 months. The control group will receive a daily unit of
 yogurt not supplemented with plant sterol esters that has a similar appearance to the
 enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and
 24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy
 product, adverse effects, adherence to dietary recommendations, frequency of food
 consumption, basic physical examination data, health problems, lipid-lowering medication,
 physical activity, smoking habits and socio-demographic variables.
Inclusion Criteria:

 -  Subjects diagnosed with limit hypercholesterolaemia (total cholesterol 200-249 mg/dl)
 or defined hypercholesterolaemia (total cholesterol equal to or above 250 mg/dl) who
 have LDL-cholesterol levels equal to or above 130 mg/dl

 -  Subjects aged 18 years or over attending the participating health centres

 -  Subjects who give their consent to participate after being informed of the study
 objectives

 Exclusion Criteria:

 -  Known hypersensitivity to sterol esters or to the other components of the food that
 contains them (liquid yoghurt)

 -  Contraindication for treatment with sterol esters or any of the components of the food

 -  Physical disability that hinders collaboration

 -  Significant chronic organic or psychiatric disease

 -  Not obtaining informed consent