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

Gerencia de Atención Primaria, Albacete

Status: Unknown

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Plant stanol esters

Study type: Interventional

Funder types: Other

Identifiers

NCT01406106

2009/001

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups, including a placebo group

Liquid yoghurt with plant stanol esters

Experimental group

Description:

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). It also contains: proteins 1.8 g, carbohydrates 9.8 g, fat 1.4 g, plant stanol 2 g, vitamin B6 0.6 mg, folic acid 60 mg.

Treatment:

Dietary Supplement: Plant stanol esters

Yoghurt without plant stanol esters

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Plant stanol esters