Hypercholesterolemia Clinical Trial
Official title:
EFFECT OF PLANT STEROLS ON THE LIPID PROFILE OF PATIENTS WITH HYPERCHOLESTEROLAEMIA. RANDOMISED, EXPERIMENTAL STUDY
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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