Clinical trial NCT01406106: Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia
Official title: EFFECT OF PLANT STEROLS ON THE LIPID PROFILE OF PATIENTS WITH HYPERCHOLESTEROLAEMIA. RANDOMISED, EXPERIMENTAL STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Lipids
Cardiovascular disease
Risks factors
Primary Care
Lead sponsor: Gerencia de Atención Primaria, Albacete
Sponsor class: OTHER
Collaborators: name: Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)
name: Castilla-La Mancha Health Research Foundation.
First posted: 2011-07-29
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in lipid profile
timeFrame: At 1, 3, 6, 12, 18 and 24 months
Secondary outcomes:
measure: Change in cardiovascular risk
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Adherence to the dairy product (liquid yoghurt)
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Adverse events
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Adherence to the dietary recommendations
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Frequency of food intake
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Occurrence of cardiovascular events
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Weight, height, body mass index (BMI)
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Physical activity
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Smoking habit
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Systolic and diastolic blood pressure (two measurements):
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Health problems
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Lipid-lowering pharmacological treatment.
timeFrame: At 1, 3, 6, 12, 18 and 24 months
measure: Socio-demographic data
timeFrame: Initial visit
Other outcomes:
Locations:
Study officials:
affiliation: Research Unit. Primary Care Head Office of Albacete
name: Ignacio Párraga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit. Primary Care Head Office of Albacete.
name: Jesús López-Torres, PhD
role: STUDY_CHAIR
affiliation: Research Unit. Primary Care Head Office of Albacete.
name: Fernando Andrés, Bachelor of Computer Sciences
role: STUDY_CHAIR
affiliation: Research Unit. Primary Care Head Office of Albacete.
name: Beatriz Navarro, PhD
role: STUDY_CHAIR
affiliation: Primary Care Head Office of Albacete.
name: José María Del Campo, PhD
role: STUDY_CHAIR
affiliation: Primary Care Head Office of Albacete.
name: Mercedes García-Reyes, PhD
role: STUDY_CHAIR
affiliation: Primary Care Head Office of Albacete.
name: María Pilar Galdón, PhD
role: STUDY_CHAIR
affiliation: Primary Care Head Office of Albacete.
name: Ángeles Lloret, Bachelor of Pharmacy
role: STUDY_CHAIR
affiliation: Primary Care Head Office of Albacete.
name: Juan Carlos Precioso, Bachelor of Medicine
role: STUDY_CHAIR
affiliation: Research Unit. Primary Care Head Office of Albacete.
name: Joseba Rabanales, Bachelor of Nursing
role: STUDY_CHAIR
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