Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatment plant stanol esters
Sponsor Gerencia de Atención Primaria, Albacete
Collaborator Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)
Start date January 2010
End date December 2011
Trial size 182 participants
Trial identifier NCT01406106, 2009/001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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.
(Placebo Comparator)
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.
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.

Primary Outcomes

Measure
Change in lipid profile
time frame: At 1, 3, 6, 12, 18 and 24 months

Secondary Outcomes

Measure
Change in cardiovascular risk
time frame: At 1, 3, 6, 12, 18 and 24 months
Adherence to the dairy product (liquid yoghurt)
time frame: At 1, 3, 6, 12, 18 and 24 months
Adverse events
time frame: At 1, 3, 6, 12, 18 and 24 months
Adherence to the dietary recommendations
time frame: At 1, 3, 6, 12, 18 and 24 months
Frequency of food intake
time frame: At 1, 3, 6, 12, 18 and 24 months
Occurrence of cardiovascular events
time frame: At 1, 3, 6, 12, 18 and 24 months
Weight, height, body mass index (BMI)
time frame: At 1, 3, 6, 12, 18 and 24 months
Physical activity
time frame: At 1, 3, 6, 12, 18 and 24 months
Smoking habit
time frame: At 1, 3, 6, 12, 18 and 24 months
Systolic and diastolic blood pressure (two measurements):
time frame: At 1, 3, 6, 12, 18 and 24 months
Health problems
time frame: At 1, 3, 6, 12, 18 and 24 months
Lipid-lowering pharmacological treatment.
time frame: At 1, 3, 6, 12, 18 and 24 months
Socio-demographic data
time frame: Initial visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title EFFECT OF PLANT STEROLS ON THE LIPID PROFILE OF PATIENTS WITH HYPERCHOLESTEROLAEMIA. RANDOMISED, EXPERIMENTAL STUDY
Principal investigator Ignacio Párraga, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Gerencia de Atención Primaria, Albacete.