Assessment of the Efficacy of Plant Stanol Esters in Reducing Cholesterol, Medellin 2011

NCT01461798 | Unknown DMC

• 1 other identifier: Ben2011
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Risk Reduction Behavior

Keywords

plant stanols; lipids; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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

  9 weeks

Study Arms (2)

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).

Dietary Supplement: assessment of efficacy of Benecol yogurt; Dietary Supplement: Placebo Yogurt

yogurt

PLACEBO COMPARATOR

Yogurt without plant stanols

Dietary Supplement: yogurt

Interventions

assessment of efficacy of Benecol yogurt DIETARY_SUPPLEMENT

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

Also known as: Benecol Yogurt, Placebo Yogurt

Benecol

Placebo Yogurt DIETARY_SUPPLEMENT

Yogurt without the active principle

Also known as: Colanta Yogurt

Benecol

yogurt DIETARY_SUPPLEMENT

yogurt without plant stanols

Also known as: Yogurt Colanta

yogurt

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jose María Maya Mejía: lead

Related Publications (9)

• Furgione A y col. Dislipidemias primarias como factor de riesgo para enfermedad coronaria.Revista latinoamericana de hipertensión. 2009;4(1)

  BACKGROUND

• 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.

  PMID: 7566021 BACKGROUND

• Schmidt 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.

  PMID: 18555851 BACKGROUND

• Katan et al. El efecto del éster estanol vegetal. Revista Europea de Nurición Clínica. 2009;63:2-10

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11002377 BACKGROUND

• Calvo Romero JM, Lima Rodriguez EM. ["Natural" treatments of hypercholesterolemia]. Rev Clin Esp. 2006 Nov;206(10):504-6. doi: 10.1157/13094900. Spanish.

  PMID: 17129518 RESULT

• Gylling 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.

  PMID: 19709787 RESULT

• Vasquez-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.

  PMID: 25099071 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior; Cardiovascular Diseases

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Johanna Romero, BML

  CES University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Romero Palacio, Microbiologa

CONTACT

300788362; jrp922@gmail.com

Elsa María Vásquez Trespalacios, Epidemióloga

CONTACT

4440555; evasquez@ces.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Johanna Romero Palacio

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 28, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 28, 2011

Record last verified: 2011-10