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| Name | Class |
|---|---|
| Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM) | UNKNOWN |
| Castilla-La Mancha Health Research Foundation. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular risk | SCORE and REGICOR tables will be used for the evaluation. | At 1, 3, 6, 12, 18 and 24 months |
| Adherence to the dairy product (liquid yoghurt) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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. |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15871776 | Background | Medrano MJ, Cerrato E, Boix R, Delgado-Rodriguez M. [Cardiovascular risk factors in Spanish population: metaanalysis of cross-sectional studies]. Med Clin (Barc). 2005 Apr 30;124(16):606-12. doi: 10.1157/13074389. Spanish. | |
| 11141438 | Background | Gutierrez Fuentes JA, Gomez-Jerique J, Gomez De La Camara A, Angel Rubio M, Garcia Hernandez A, Aristegui I; Diet and Cardiovascular Risk in Spain Study (DRECE II). [Diet and cardiovascular risk in Spain. Description of the evolution of cardiovascular prolile]. Med Clin (Barc). 2000 Dec 2;115(19):726-9. Spanish. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C407042 | plant stanol ester |
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|
| At 1, 3, 6, 12, 18 and 24 months |
| Adverse events | 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. | At 1, 3, 6, 12, 18 and 24 months |
| Adherence to the dietary recommendations | 5-point Likert scale | At 1, 3, 6, 12, 18 and 24 months |
| Frequency of food intake | Using the CDC-FFQ questionnaire, validated in Spain (Aguirre, 2008) considered appropriate to classify the subjects according to their intake of food and nutrients. | At 1, 3, 6, 12, 18 and 24 months |
| Occurrence of cardiovascular events | 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. | At 1, 3, 6, 12, 18 and 24 months |
| Weight, height, body mass index (BMI) | Classification of subjects according to degree of obesity. | At 1, 3, 6, 12, 18 and 24 months |
| Physical activity | 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). | At 1, 3, 6, 12, 18 and 24 months |
| Smoking habit | Considered smoker if answers yes to the question "do you smoke?" | At 1, 3, 6, 12, 18 and 24 months |
| Systolic and diastolic blood pressure (two measurements): | The result will be the mean of the two measurements. | At 1, 3, 6, 12, 18 and 24 months |
| Health problems | (WONCA ICPC-2) | At 1, 3, 6, 12, 18 and 24 months |
| Lipid-lowering pharmacological treatment. | Whether taking lipid-lowering pharmacological treatment. | At 1, 3, 6, 12, 18 and 24 months |
| Socio-demographic data | Age, gender, marital status, educational level and social class based on occupation (National Classification of Occupations). | Initial visit |
| Study Chair |
| Joseba Rabanales, Bachelor of Nursing | Research Unit. Primary Care Head Office of Albacete. | Study Chair |
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| 25541227 | Derived | Parraga-Martinez I, Lopez-Torres-Hidalgo JD, Del Campo-Del Campo JM, Galdon-Blesa MP, Precioso-Yanez JC, Rabanales-Sotos J, Garcia-Reyes-Ramos M, Andres-Pretel F, Navarro-Bravo B, Lloret-Callejo A. Long-term Effects of Plant Stanols on the Lipid Profile of Patients With Hypercholesterolemia. A Randomized Clinical Trial. Rev Esp Cardiol (Engl Ed). 2015 Aug;68(8):665-71. doi: 10.1016/j.rec.2014.07.035. Epub 2014 Dec 23. |
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| D009750 |
| Nutritional and Metabolic Diseases |