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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Gerencia de Atención Primaria, Albacete.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)
Castilla-La Mancha Health Research Foundation.
Information provided by:
Gerencia de Atención Primaria, Albacete
ClinicalTrials.gov Identifier:
NCT01406106
First received: July 28, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: Plant stanol esters

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECT OF PLANT STEROLS ON THE LIPID PROFILE OF PATIENTS WITH HYPERCHOLESTEROLAEMIA. RANDOMISED, EXPERIMENTAL STUDY

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Albacete:

Primary Outcome Measures:
  • Change in lipid profile [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in cardiovascular risk [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    SCORE and REGICOR tables will be used for the evaluation.

  • Adherence to the dairy product (liquid yoghurt) [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    By self-report and Morisky-Green scale, which determines the degree of coincidence between the patient's behaviour and the doctor's advice (a non-complier is one who answers one of the four questions of the scale inappropriately).

  • Adverse events [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
    Considered as any undesirable event in any patient included in the study, even though it does not have a causal relation with the product. Known adverse events of phytosterols in the diet at the proposed doses: occasionally mild digestive alterations.

  • Adherence to the dietary recommendations [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    5-point Likert scale

  • Frequency of food intake [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Using the CDC-FFQ questionnaire, validated in Spain (Aguirre, 2008) considered appropriate to classify the subjects according to their intake of food and nutrients.

  • Occurrence of cardiovascular events [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

    Ischaemic heart disease, atherothrombotic cerebrovascular disease, heart failure and peripheral artery disease.

    -Weight, height, body mass index (BMI): classification of subjects according to degree of obesity.


  • Weight, height, body mass index (BMI) [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Classification of subjects according to degree of obesity.

  • Physical activity [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Amount of aerobic exercise ("active" if performs aerobic exercise for 30 minutes or more, three or more times a week, "partially active" if exercises with less frequency and for less time that this and "inactive" when does not perform any type of exercise).

  • Smoking habit [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Considered smoker if answers yes to the question "do you smoke?"

  • Systolic and diastolic blood pressure (two measurements): [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    The result will be the mean of the two measurements.

  • Health problems [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    (WONCA ICPC-2)

  • Lipid-lowering pharmacological treatment. [ Time Frame: At 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Whether taking lipid-lowering pharmacological treatment.

  • Socio-demographic data [ Time Frame: Initial visit ] [ Designated as safety issue: No ]
    Age, gender, marital status, educational level and social class based on occupation (National Classification of Occupations).


Enrollment: 182
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liquid yoghurt with plant stanol esters

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
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: Yoghurt without plant stanol esters
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406106

Sponsors and Collaborators
Gerencia de Atención Primaria, Albacete
Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)
Castilla-La Mancha Health Research Foundation.
Investigators
Principal Investigator: Ignacio Párraga, PhD Research Unit. Primary Care Head Office of Albacete
Study Chair: 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.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignacio Párraga Martínez, Gerencia de Atención Primaria de Albacete
ClinicalTrials.gov Identifier: NCT01406106     History of Changes
Other Study ID Numbers: 2009/001
Study First Received: July 28, 2011
Last Updated: July 28, 2011
Health Authority: Spain: Marketing authorisation on 31st March 2004 under regulation (EC) No. 258/97 of the European Parliament for products such as yoghurt with added plant sterol esters as a novel food or novel food ingredient. According to the Spanish Medicines Agency,

Keywords provided by Gerencia de Atención Primaria, Albacete:
Hypercholesterolemia
Lipids
Cardiovascular disease
Risks factors
Primary Care

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014