Open Access Study protocol

Effect of plant sterols on the lipid profile of patients with hypercholesterolaemia. Randomised, experimental study

Ignacio Párraga1*, Jesús López-Torres1, Fernando Andrés1, Beatriz Navarro1, José M del Campo2, Mercedes García-Reyes3, María P Galdón4, Ángeles Lloret5, Juan C Precioso4 and Joseba Rabanales1

Author Affiliations

1 Research Unit, Primary Care Head Office of Albacete, Health Care Service of Castilla-La Mancha, Marqués de Villores 6-8, 02001 Albacete, Spain

2 Almansa Health Centre, Health Care Service of Castilla-La Mancha, C/San Juan s/n, 02640 Almansa, Albacete, Spain

3 Albacete Area III Health Centre, Health Care Service of Castilla-La Mancha, Plaza La Mancha s/n, 02001 Albacete, Spain

4 La Roda Health Centre, Health Care Service of Castilla-La Mancha, C/Martínez 63, 02630 La Roda, Albacete, Spain

5 Pharmacy Service, Primary Care Head Office of Albacete, Health Care Service of Castilla-La Mancha, Marqués de Villores 6-8, 02001 Albacete, Spain

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BMC Complementary and Alternative Medicine 2011, 11:73  doi:10.1186/1472-6882-11-73

Published: 12 September 2011

Abstract

Background

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 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.

Methods/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.

Discussion

If plant sterol ester supplements were effective a sounder recommendation for the consumption of plant sterols in subjects with hypercholesterolaemia could be made.

Trial Registration

Current Controlled Trials NCT01406106.