Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia

Summary

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.

Conditions

• Hypercholesterolemia

Interventions

DIETARY_SUPPLEMENT

Plant stanol esters

The administration of a dairy product in the form of liquid yoghurt, marketed in Spain, that contains 2 g per container of plant stanol esters: sitostanol and campestanol (AHA recommended dose - 1.5 to 3 g). The enriched product and the placebo will have the same characteristics (composition and outward appearance), but the placebo will not contain stanol esters. The dose will be one container a day, after the main meal, for 24 months. The participants may continue with their previously prescribed lipid-lowering treatment and new treatment needed for this disease or for other diseases. Composition per container: proteins 1.8 g, carbohydrates 9.8 g, fat (except stanol) 1.4 g, plant stanol 2 g, vitamin B6 0.6 mg, folic acid 60 mg. The control group will receive one unit a day of yoghurt not supplemented with stanol esters that has a similar appearance to the enriched yoghurt.

Sponsors & Collaborators

• Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)

  collaborator UNKNOWN

• Castilla-La Mancha Health Research Foundation.

  collaborator UNKNOWN

• Gerencia de Atención Primaria, Albacete

  lead OTHER

Principal Investigators

• Ignacio Párraga, PhD · Research Unit. Primary Care Head Office of Albacete

• Jesús López-Torres, PhD · Research Unit. Primary Care Head Office of Albacete.

• Fernando Andrés, Bachelor of Computer Sciences · Research Unit. Primary Care Head Office of Albacete.

• Beatriz Navarro, PhD · Research Unit. Primary Care Head Office of Albacete.

• José María Del Campo, PhD · Primary Care Head Office of Albacete.

• Mercedes García-Reyes, PhD · Primary Care Head Office of Albacete.

• María Pilar Galdón, PhD · Primary Care Head Office of Albacete.

• Ángeles Lloret, Bachelor of Pharmacy · Primary Care Head Office of Albacete.

• Juan Carlos Precioso, Bachelor of Medicine · Primary Care Head Office of Albacete.

• Joseba Rabanales, Bachelor of Nursing · Research Unit. Primary Care Head Office of Albacete.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-12-31

Completion

2012-12-31