Risk Reduction BehaviorBen2011NCT01461798
Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011
A study testing assessment of efficacy of Benecol yogurt and yogurt in people with Risk Reduction Behavior, run by Jose María Maya Mejía.
Trial summary
Introduction: Cardiovascular diseases have become the leading cause of death from chronic diseases in the world. One of the major risk factors for this disease is hypercholesterolemia, caused in most cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is plant stanol ester that… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Risk Reduction Behavior
- What is being tested?
- assessment of efficacy of Benecol yogurt and yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sign voluntarily the informed consent
- Male or female 20 to 50 years
- The concentration of total serum cholesterol of 5.2 - 7.5 mmol / l (205-290 mg / dl) at the screening visit (Visit 1 to 2 week)
Who cannot join
- Lipid-lowering medication or other drugs that significantly affect lipid values
- Diabetes Type I or II
- Severe obesity (BMI greater than 35 kg/m2)
- Fasting serum triglycerides> 4.0 mmol / l
- Liver or kidney disorder according to medical history
- History of coronary revascularization percutaneous transluminal coronary angioplasty within six months prior to screening
Show all 13Show fewer
- History of temporary ischemic attack or stroke within six months prior to screening
- History of cancer or other malignant disease in the last five years
- Consumption of more than 15 parts of alcohol/week
- Pregnant or lactating
- Benecol consumption in your diet, or other plant sterol enriched products 30 days before visit 2 (Week 1), these will be identified by the survey
- Severe lactose intolerance, milk allergy or any other form of intolerance to the ingredients of the test products
- Celiac Disease
Trial locations and contacts
No sites are listed yet.
About this study
Introduction:
Cardiovascular diseases have become the leading cause of death from chronic diseases in the world. One of the major risk factors for this disease is hypercholesterolemia, caused in most cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is plant stanol ester that competes with total cholesterol and low density lipoprotein or LDL cholesterol by preventing them to be absorbed by the body and reducing blood levels.
Read more
Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.
Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES control clinic in Medellin.
Expected results: Test the effectiveness of plant stanol esters in reducing total cholesterol and LDL cholesterol in patients with moderate hypercholesterolemia.
Read the detailed description
The main cause of death worldwide are cardiovascular diseases, generated mainly by disturbances in the lipid profile. Several studies have shown that dyslipidemia is an important risk factor for this condition, thus maintaining the level of lipids in an appropriate range is ideal for preventing cardiovascular diseases (1)
Cardiovascular diseases are a serious epidemiological problem in the contemporary world, with approximately 17 million people die each year from causes such as myocardial infarction and stroke. The increase in cardiovascular disease and mortality attributable to them is a topic widely reported by several authors in the world. In Colombia after death from violent causes, cardiovascular diseases are on the second of the five leading causes of mortality in the general population.
Having high total cholesterol is a risk factor for the occurrence of various diseases of the circulatory system, therefore it is important to keep total cholesterol below 200 mg / dl and LDL cholesterol levels under 150 mg/dl, to avoid the accumulation of fat within the walls of the arteries that can lead to the formation of atherosclerotic plaques that cause decreased blood flow
The atlas published by WHO in 2005 provides comprehensive data on morbidity and mortality attributable to noncommunicable diseases, which are increasing. It is estimated that in 2001 approximately 60% of the 56.5 million deaths worldwide and 46% of diseases are due to noncommunicable diseases. The epidemiological burden of these diseases will increase to 57% by the year 2020. Almost 50% of deaths due to noncommunicable diseases are due to cardiovascular disease. By 2020, these diseases are responsible for 75% of all deaths worldwide.
Given the high prevalence of cardiovascular disease and dyslipidemia are considered a high risk factor for these occur, it is necessary to test the effectiveness of including the consumption of plant stanol esters in the diet to lower cholesterol values Total and LDL Cholesterol.
- Conditions
- Risk Reduction Behavior
- Being tested
- assessment of efficacy of Benecol yogurt, Placebo Yogurt, yogurt
- Keywords
- plant stanols, lipids, cardiovascular disease
- Medical subject headings
- Risk Reduction Behavior, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of efficacy of Benecol yogurtDietary supplement
Also called Benecol Yogurt, Placebo Yogurt
Benecol Yogurt and Yogurt placebo for 4 weeks each, at a dose of 100 ml (200 ml in total) of yogurt twice a day with main meals
Placebo YogurtDietary supplement
Also called Colanta Yogurt
Yogurt without the active principle
yogurtDietary supplement
Also called Yogurt Colanta
yogurt without plant stanols
| Study group | Role | What they receive |
|---|---|---|
| Benecol | Experimental | In 2009, the dairy Cooperative Colanta Launches Benecol ® yogurt, a product with optimal daily dose of plant stanol, each portion of 100 g containing 3.4 g of Benecol ®, corresponding to 2 g of plant stanol esters . Skim yogurt with Benecol ® is a product made from pasteurized skim milk, sweetened with sucralose homogenized and fermented by the action of specific lactic culture to obtain the optimal characteristics of texture and acidity. With the addition of fruit pulp and supplemented with plant stanol esters (Benecol ®) to help reduce the risk of cardiovascular disease (31). According to Weiss et al, drinkable yogurt with Benecol ® reduces total cholesterol by 5.8% and 9.8% in LDL cholesterol (32). Receives: Dietary Supplement: assessment of efficacy of Benecol yogurt; Dietary Supplement: Placebo Yogurt |
| yogurt | Placebo comparator | Yogurt without plant stanols Receives: Dietary Supplement: yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benecol Efficacy
Week 1: it will be taken a blood sample for lipid profile and other tests of liver and kidney function, patients will begin the Benecol ® yogurt consumption or placebo for four weeks, at week 5 it will be taken a new blood sample to perform mentioned test lipid levels and meet and determine the changes presented, patients will have a wash out week in Week 6 and groups will change for four weeks, at the end of week 9 will be held the last shot of sample for all tests again
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Risk Reduction BehaviorStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose María Maya Mejía
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose María Maya Mejía, CES University
- Investigators
- Johanna Romero, BML, Principal investigator, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461798
- Sponsor's protocol ID
- Ben2011
- Acronym
- Ben2011
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Furgione A y col. Dislipidemias primarias como factor de riesgo para enfermedad coronaria.Revista latinoamericana de hipertensión. 2009;4(1)
Miettinen 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 7566021Schmidt B, Ribnicky DM, Poulev A, Logendra S, Cefalu WT, Raskin I. A natural history of botanical therapeutics. Metabolism. 2008 Jul;57(7 Suppl 1):S3-9. doi: 10.1016/j.metabol.2008.03.001.
PubMed 18555851Katan et al. El efecto del éster estanol vegetal. Revista Europea de Nurición Clínica. 2009;63:2-10
Musa-Veloso K et al. Una comparación entre la eficacia para disminuir el colesterol - LDL de los estanoles vegetales y los esteroles vegetales dentro de un rango de dosis continúo: Resultados de un meta-análisis de estudios controlados randomizados con placebo. 2011
Plat J, van Onselen EN, van Heugten MM, Mensink RP. Effects on serum lipids, lipoproteins and fat soluble antioxidant concentrations of consumption frequency of margarines and shortenings enriched with plant stanol esters. Eur J Clin Nutr. 2000 Sep;54(9):671-7. doi: 10.1038/sj.ejcn.1601071.
PubMed 11002377Calvo Romero JM, Lima Rodriguez EM. ["Natural" treatments of hypercholesterolemia]. Rev Clin Esp. 2006 Nov;206(10):504-6. doi: 10.1157/13094900. Spanish.
PubMed 17129518Gylling H, Hallikainen M, Nissinen MJ, Miettinen TA. The effect of a very high daily plant stanol ester intake on serum lipids, carotenoids, and fat-soluble vitamins. Clin Nutr. 2010 Feb;29(1):112-8. doi: 10.1016/j.clnu.2009.08.005. Epub 2009 Aug 26.
PubMed 19709787Vasquez-Trespalacios EM, Romero-Palacio J. Efficacy of yogurt drink with added plant stanol esters (Benecol(R), Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798. Lipids Health Dis. 2014 Aug 6;13:125. doi: 10.1186/1476-511X-13-125.
PubMed 25099071
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011
- ClinicalTrials.gov ID
- NCT01461798
- Acronym / sponsor ID
- Ben2011 / Ben2011
- Conditions
- Risk Reduction Behavior
- Keywords
- plant stanols, lipids, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jose María Maya MejíaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 28 Oct 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.
Introduction:
Cardiovascular diseases have become the leading cause of death from chronic diseases in the world. One of the major risk factors for this disease is hypercholesterolemia, caused in most cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is plant stanol ester that competes with total cholesterol and low density lipoprotein or LDL cholesterol by preventing them to be absorbed by the body and reducing blood levels.
Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.
Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES control clinic in Medellin.
Expected results: Test the effectiveness of plant stanol esters in reducing total cholesterol and LDL cholesterol in patients with moderate hypercholesterolemia.
Detailed description
The main cause of death worldwide are cardiovascular diseases, generated mainly by disturbances in the lipid profile. Several studies have shown that dyslipidemia is an important risk factor for this condition, thus maintaining the level of lipids in an appropriate range is ideal for preventing cardiovascular diseases (1)
Cardiovascular diseases are a serious epidemiological problem in the contemporary world, with approximately 17 million people die each year from causes such as myocardial infarction and stroke. The increase in cardiovascular disease and mortality attributable to them is a topic widely reported by several authors in the world. In Colombia after death from violent causes, cardiovascular diseases are on the second of the five leading causes of mortality in the general population.
Having high total cholesterol is a risk factor for the occurrence of various diseases of the circulatory system, therefore it is important to keep total cholesterol below 200 mg / dl and LDL cholesterol levels under 150 mg/dl, to avoid the accumulation of fat within the walls of the arteries that can lead to the formation of atherosclerotic plaques that cause decreased blood flow
The atlas published by WHO in 2005 provides comprehensive data on morbidity and mortality attributable to noncommunicable diseases, which are increasing. It is estimated that in 2001 approximately 60% of the 56.5 million deaths worldwide and 46% of diseases are due to noncommunicable diseases. The epidemiological burden of these diseases will increase to 57% by the year 2020. Almost 50% of deaths due to noncommunicable diseases are due to cardiovascular disease. By 2020, these diseases are responsible for 75% of all deaths worldwide.
Given the high prevalence of cardiovascular disease and dyslipidemia are considered a high risk factor for these occur, it is necessary to test the effectiveness of including the consumption of plant stanol esters in the diet to lower cholesterol values Total and LDL Cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benecol | Experimental | Dietary Supplement: assessment of efficacy of Benecol yogurt, Dietary Supplement: Placebo YogurtIn 2009, the dairy Cooperative Colanta Launches Benecol ® yogurt, a product with optimal daily dose of plant stanol, each portion of 100 g containing 3.4 g of Benecol ®, corresponding to 2 g of plant stanol esters . Skim yogurt with Benecol ® is a product made from pasteurized skim milk, sweetened with sucralose homogenized and fermented by the action of specific lactic culture to obtain the optimal characteristics of texture and acidity. With the addition of fruit pulp and supplemented with plant stanol esters (Benecol ®) to help reduce the risk of cardiovascular disease (31). According to Weiss et al, drinkable yogurt with Benecol ® reduces total cholesterol by 5.8% and 9.8% in LDL cholesterol (32). |
| yogurt | Placebo comparator | Dietary Supplement: yogurtYogurt without plant stanols |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sign voluntarily the informed consent
- Male or female 20 to 50 years
- The concentration of total serum cholesterol of 5.2 - 7.5 mmol / l (205-290 mg / dl) at the screening visit (Visit 1 to 2 week)
Key exclusion criteria (13 listed)
- Lipid-lowering medication or other drugs that significantly affect lipid values
- Diabetes Type I or II
- Severe obesity (BMI greater than 35 kg/m2)
- Fasting serum triglycerides> 4.0 mmol / l
- Liver or kidney disorder according to medical history
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 |
|---|---|---|
| assessment of efficacy of Benecol yogurtAlso: Benecol Yogurt, Placebo YogurtBenecol Yogurt and Yogurt placebo for 4 weeks each, at a dose of 100 ml (200 ml in total) of yogurt twice a day with main meals | Dietary supplement | Benecol |
| Placebo YogurtAlso: Colanta YogurtYogurt without the active principle | Dietary supplement | Benecol |
| yogurtAlso: Yogurt Colantayogurt without plant stanols | Dietary supplement | yogurt |
Primary outcome
Benecol Efficacy
Time frame: 9 weeks
Week 1: it will be taken a blood sample for lipid profile and other tests of liver and kidney function, patients will begin the Benecol ® yogurt consumption or placebo for four weeks, at week 5 it will be taken a new blood sample to perform mentioned test lipid levels and meet and determine the changes presented, patients will have a wash out week in Week 6 and groups will change for four weeks, at the end of week 9 will be held the last shot of sample for all tests again
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- BackgroundFurgione A y col. Dislipidemias primarias como factor de riesgo para enfermedad coronaria.Revista latinoamericana de hipertensión. 2009;4(1)
- Background: PubMed 7566021Miettinen 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.
- Background: PubMed 18555851Schmidt B, Ribnicky DM, Poulev A, Logendra S, Cefalu WT, Raskin I. A natural history of botanical therapeutics. Metabolism. 2008 Jul;57(7 Suppl 1):S3-9. doi: 10.1016/j.metabol.2008.03.001.
- BackgroundKatan et al. El efecto del éster estanol vegetal. Revista Europea de Nurición Clínica. 2009;63:2-10
- BackgroundMusa-Veloso K et al. Una comparación entre la eficacia para disminuir el colesterol - LDL de los estanoles vegetales y los esteroles vegetales dentro de un rango de dosis continúo: Resultados de un meta-análisis de estudios controlados randomizados con placebo. 2011
- Background: PubMed 11002377Plat J, van Onselen EN, van Heugten MM, Mensink RP. Effects on serum lipids, lipoproteins and fat soluble antioxidant concentrations of consumption frequency of margarines and shortenings enriched with plant stanol esters. Eur J Clin Nutr. 2000 Sep;54(9):671-7. doi: 10.1038/sj.ejcn.1601071.
- Results publication: PubMed 17129518Calvo Romero JM, Lima Rodriguez EM. ["Natural" treatments of hypercholesterolemia]. Rev Clin Esp. 2006 Nov;206(10):504-6. doi: 10.1157/13094900. Spanish.
- Results publication: PubMed 19709787Gylling H, Hallikainen M, Nissinen MJ, Miettinen TA. The effect of a very high daily plant stanol ester intake on serum lipids, carotenoids, and fat-soluble vitamins. Clin Nutr. 2010 Feb;29(1):112-8. doi: 10.1016/j.clnu.2009.08.005. Epub 2009 Aug 26.
- Derived from this study: PubMed 25099071Vasquez-Trespalacios EM, Romero-Palacio J. Efficacy of yogurt drink with added plant stanol esters (Benecol(R), Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798. Lipids Health Dis. 2014 Aug 6;13:125. doi: 10.1186/1476-511X-13-125.
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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.
Johanna Romero, BML principal investigator
CES University
Questions about this trial
What is this clinical trial studying?
A study testing assessment of efficacy of Benecol yogurt and yogurt in people with Risk Reduction Behavior, run by Jose María Maya Mejía.
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 13 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 28 Oct 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?
Contact Johanna Romero Palacio, Microbiologa (300788362, jrp922@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benecol Efficacy (time frame: 9 weeks). 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 NCT01461798, which also lists 9 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 28 Oct 2011; AzTrials last refreshed its copy on 8 Nov 2026.