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

NCT01406106 | Unknown

• 1 other identifier: 2009/001
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Lipids; Cardiovascular disease; Risks factors; Primary Care

Outcome Measures

Primary Outcomes (1)

• Change in lipid profile

  Lipid levels will be measured in both plasma and capillary blood at the initial visit. The validity of the capillary blood lipid levels can be checked with the Cardiochek analyser (by total cholesterol, HDL-cholesterol and triglyceride strips, and subsequent calculation of LDL-cholesterol using the Friedewald formula). The measurements at 3, 12 and 24 months will be in plasma. At 1, 6 and 18 months they will only be in capillary blood.

  At 1, 3, 6, 12, 18 and 24 months

Secondary Outcomes (13)

• Change in cardiovascular risk

  At 1, 3, 6, 12, 18 and 24 months

• Adherence to the dairy product (liquid yoghurt)

  At 1, 3, 6, 12, 18 and 24 months

• Adverse events

  At 1, 3, 6, 12, 18 and 24 months

• Adherence to the dietary recommendations

  At 1, 3, 6, 12, 18 and 24 months

• Frequency of food intake

  At 1, 3, 6, 12, 18 and 24 months

Study Arms (2)

Liquid yoghurt with plant stanol esters

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.

Dietary Supplement: Plant stanol esters

Yoghurt without plant stanol esters

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.

Dietary Supplement: Plant stanol esters

Interventions

Plant stanol esters DIETARY_SUPPLEMENT

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.

Liquid yoghurt with plant stanol esters; Yoghurt without plant stanol esters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerencia de Atención Primaria, Albacete: lead
• Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM): collaborator
• Castilla-La Mancha Health Research Foundation.: collaborator

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MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ignacio Párraga, PhD

  Research Unit. Primary Care Head Office of Albacete

  PRINCIPAL INVESTIGATOR

• Jesús López-Torres, PhD

  Research Unit. Primary Care Head Office of Albacete.

  STUDY CHAIR

• Fernando Andrés, Bachelor of Computer Sciences

  Research Unit. Primary Care Head Office of Albacete.

  STUDY CHAIR

• Beatriz Navarro, PhD

  Research Unit. Primary Care Head Office of Albacete.

  STUDY CHAIR

• José María Del Campo, PhD

  Primary Care Head Office of Albacete.

  STUDY CHAIR

• Mercedes García-Reyes, PhD

  Primary Care Head Office of Albacete.

  STUDY CHAIR

• María Pilar Galdón, PhD

  Primary Care Head Office of Albacete.

  STUDY CHAIR

• Ángeles Lloret, Bachelor of Pharmacy

  Primary Care Head Office of Albacete.

  STUDY CHAIR

• Juan Carlos Precioso, Bachelor of Medicine

  Primary Care Head Office of Albacete.

  STUDY CHAIR

• Joseba Rabanales, Bachelor of Nursing

  Research Unit. Primary Care Head Office of Albacete.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 29, 2011

Record last verified: 2011-07