HypercholesterolemiaNCT01406106
Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia
A study testing Plant stanol esters in people with Hypercholesterolemia, run by Gerencia de Atención Primaria, Albacete.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Plant stanol esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Plant stanol esters
- Keywords
- Hypercholesterolemia, Lipids, Cardiovascular disease, Risks factors, Primary Care
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant stanol estersDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Plant stanol esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1, 3, 6, 12, 18 and 24 months
Secondary outcomes (13)
Change in cardiovascular risk
SCORE and REGICOR tables will be used for the evaluation.
Measured: 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).
Measured: 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.
Measured: At 1, 3, 6, 12, 18 and 24 months
Adherence to the dietary recommendations
5-point Likert scale
Measured: 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.
Measured: 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.
Measured: At 1, 3, 6, 12, 18 and 24 months
Weight, height, body mass index (BMI)
Classification of subjects according to degree of obesity.
Measured: 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).
Measured: At 1, 3, 6, 12, 18 and 24 months
Smoking habit
Considered smoker if answers yes to the question "do you smoke?"
Measured: 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.
Measured: At 1, 3, 6, 12, 18 and 24 months
Health problems
(WONCA ICPC-2)
Measured: At 1, 3, 6, 12, 18 and 24 months
Lipid-lowering pharmacological treatment.
Whether taking lipid-lowering pharmacological treatment.
Measured: 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).
Measured: Initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Albacete
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM), Castilla-La Mancha Health Research Foundation.
- Investigators
- Ignacio Párraga, PhD, Principal investigator, Research Unit. Primary Care Head Office of AlbaceteJesús López-Torres, PhD, Study chair, Research Unit. Primary Care Head Office of Albacete.Fernando Andrés, Bachelor of Computer Sciences, Study chair, Research Unit. Primary Care Head Office of Albacete.Beatriz Navarro, PhD, Study chair, Research Unit. Primary Care Head Office of Albacete.José María Del Campo, PhD, Study chair, Primary Care Head Office of Albacete.Mercedes García-Reyes, PhD, Study chair, Primary Care Head Office of Albacete.María Pilar Galdón, PhD, Study chair, Primary Care Head Office of Albacete.Ángeles Lloret, Bachelor of Pharmacy, Study chair, Primary Care Head Office of Albacete.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406106
- Sponsor's protocol ID
- 2009/001
- Status last verified
- Jul 2011
- First submitted
- 28 Jul 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15871776Gutierrez 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.
PubMed 11141438Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994 Feb 5;308(6925):367-72. doi: 10.1136/bmj.308.6925.367.
PubMed 8043072Law MR, Wald NJ. Risk factor thresholds: their existence under scrutiny. BMJ. 2002 Jun 29;324(7353):1570-6. doi: 10.1136/bmj.324.7353.1570. No abstract available.
PubMed 12089098Keys A. Coronary heart disease, serum cholesterol, and the diet. Acta Med Scand. 1980;207(3):153-60. doi: 10.1111/j.0954-6820.1980.tb09697.x. No abstract available.
PubMed 7368981Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
PubMed 16214597McCullough ML, Feskanich D, Stampfer MJ, Giovannucci EL, Rimm EB, Hu FB, Spiegelman D, Hunter DJ, Colditz GA, Willett WC. Diet quality and major chronic disease risk in men and women: moving toward improved dietary guidance. Am J Clin Nutr. 2002 Dec;76(6):1261-71. doi: 10.1093/ajcn/76.6.1261.
PubMed 12450892Sudhop T, von Bergmann K. Cholesterol absorption inhibitors for the treatment of hypercholesterolaemia. Drugs. 2002;62(16):2333-47. doi: 10.2165/00003495-200262160-00002.
PubMed 12396226Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380.
PubMed 15699225Bellisle F, Blundell JE, Dye L, Fantino M, Fern E, Fletcher RJ, Lambert J, Roberfroid M, Specter S, Westenhofer J, Westerterp-Plantenga MS. Functional food science and behaviour and psychological functions. Br J Nutr. 1998 Aug;80 Suppl 1:S173-93. doi: 10.1079/bjn19980109.
PubMed 9849358Ros E. [Introduction to functional food]. Med Clin (Barc). 2001 May 5;116(16):617-9. doi: 10.1016/s0025-7753(01)71924-0. No abstract available. Spanish.
PubMed 11412648Silveira Rodriguez MB, Monereo Megias S, Molina Baena B. [Functional nutrition and optimal nutrition. Near or far?]. Rev Esp Salud Publica. 2003 May-Jun;77(3):317-31. Spanish.
PubMed 12852326Cater NB. Plant stanol ester: review of cholesterol-lowering efficacy and implications for coronary heart disease risk reduction. Prev Cardiol. 2000 Summer;3(3):121-130. doi: 10.1111/j.1520-037x.2000.80370.x.
PubMed 11834929Hallikainen MA, Sarkkinen ES, Uusitupa MI. Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner. J Nutr. 2000 Apr;130(4):767-76. doi: 10.1093/jn/130.4.767.
PubMed 10736328Miettinen TA, Puska P, Gylling H, Vanhanen H, Vartiainen E. Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. N Engl J Med. 1995 Nov 16;333(20):1308-12. doi: 10.1056/NEJM199511163332002.
PubMed 7566021
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PLANT STEROLS ON THE LIPID PROFILE OF PATIENTS WITH HYPERCHOLESTEROLAEMIA. RANDOMISED, EXPERIMENTAL STUDY
- ClinicalTrials.gov ID
- NCT01406106
- Acronym / sponsor ID
- 2009/001
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Lipids, Cardiovascular disease, Risks factors, Primary Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, AlbaceteUniversity, hospital or other
- Collaborators
- Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM), Castilla-La Mancha Health Research Foundation.
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid yoghurt with plant stanol esters | Experimental | Dietary Supplement: Plant stanol estersDairy 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 | Dietary Supplement: Plant stanol estersComposition 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant stanol estersThe 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. | Dietary supplement | Liquid yoghurt with plant stanol esters, Yoghurt without plant stanol esters |
Primary outcome
Change in lipid profile
Time frame: At 1, 3, 6, 12, 18 and 24 months
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.
13 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Background: PubMed 15871776Medrano 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.
- Background: PubMed 11141438Gutierrez 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.
- Background: PubMed 8043072Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994 Feb 5;308(6925):367-72. doi: 10.1136/bmj.308.6925.367.
- Background: PubMed 12089098Law MR, Wald NJ. Risk factor thresholds: their existence under scrutiny. BMJ. 2002 Jun 29;324(7353):1570-6. doi: 10.1136/bmj.324.7353.1570. No abstract available.
- Background: PubMed 7368981Keys A. Coronary heart disease, serum cholesterol, and the diet. Acta Med Scand. 1980;207(3):153-60. doi: 10.1111/j.0954-6820.1980.tb09697.x. No abstract available.
- Background: PubMed 16214597Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
- Background: PubMed 12450892McCullough ML, Feskanich D, Stampfer MJ, Giovannucci EL, Rimm EB, Hu FB, Spiegelman D, Hunter DJ, Colditz GA, Willett WC. Diet quality and major chronic disease risk in men and women: moving toward improved dietary guidance. Am J Clin Nutr. 2002 Dec;76(6):1261-71. doi: 10.1093/ajcn/76.6.1261.
- Background: PubMed 12396226Sudhop T, von Bergmann K. Cholesterol absorption inhibitors for the treatment of hypercholesterolaemia. Drugs. 2002;62(16):2333-47. doi: 10.2165/00003495-200262160-00002.
- Background: PubMed 15699225Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380.
- Background: PubMed 9849358Bellisle F, Blundell JE, Dye L, Fantino M, Fern E, Fletcher RJ, Lambert J, Roberfroid M, Specter S, Westenhofer J, Westerterp-Plantenga MS. Functional food science and behaviour and psychological functions. Br J Nutr. 1998 Aug;80 Suppl 1:S173-93. doi: 10.1079/bjn19980109.
- Background: PubMed 11412648Ros E. [Introduction to functional food]. Med Clin (Barc). 2001 May 5;116(16):617-9. doi: 10.1016/s0025-7753(01)71924-0. No abstract available. Spanish.
- Background: PubMed 12852326Silveira Rodriguez MB, Monereo Megias S, Molina Baena B. [Functional nutrition and optimal nutrition. Near or far?]. Rev Esp Salud Publica. 2003 May-Jun;77(3):317-31. Spanish.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Párraga, PhD principal investigator
Research Unit. Primary Care Head Office of Albacete
Jesús López-Torres, PhD study chair
Research Unit. Primary Care Head Office of Albacete.
Fernando Andrés, Bachelor of Computer Sciences study chair
Research Unit. Primary Care Head Office of Albacete.
Questions about this trial
What is this clinical trial studying?
A study testing Plant stanol esters in people with Hypercholesterolemia, run by Gerencia de Atención Primaria, Albacete.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipid profile (time frame: At 1, 3, 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406106, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.