Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol (LDL-c), and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors.
Drug: Plantago ovata husk
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Multicentre, Comparative, Double-Blind, Two-Arm Parallel Clinical Trial of the Effects of Treatment With Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia|
- To determine the capacity to reduce by 5% the concentrations of plasma LDL-c by treatment with soluble fibre-Plantago ovata husk- added to a low saturated fat diet in patients with moderate hypercholesterolemia. [ Time Frame: 16 weeks ]
- To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective [ Time Frame: 16 weeks ]
- To analyse the effect of Plantago ovata husk fibre on blood pressure [ Time Frame: 16 weeks ]
- To evaluate whether the response on plasma lipids is modulated by the polymorphisms of apolipoprotein E, cholesterol ester transfer protein (CETP), apolipoprotein A-V and Fatty acid binding protein 2 (FABP2) [ Time Frame: 16 weeks ]
|Study Start Date:||September 2005|
|Study Completion Date:||July 2007|
It has been demonstrated that high concentrations of cholesterol and low density lipoprotein cholesterol (LDL, high risk cholesterol) are the major risk factors for heart disease, myocardial infarction and angina pectoris. Moreover, these conditions represent the major cause of death in the Western world.
Of the measures established to reduce blood cholesterol levels, the introduction of consumption of dietary fibre is a novelty. The term dietary fibre defines a variety of substances that are found in plants and are resistant to digestion by human gastrointestinal enzymes.
The studies performed up until now to determine the effects of fibre on blood lipids have demonstrated that consumption of soluble fibre can reduce cholesterol.
|Hosp. Universitario San Joan de Reus, (Spain)|
|Reus, Tarragona, Spain, 43201|
|Study Chair:||Rosa Solà, MD, phD||Hosp. Universitario San Joan de Reus , Spain|
|Principal Investigator:||Manuel Castro, MD, phD||Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)|
|Principal Investigator:||Eric Brucker, MD, phD||Hosp. de la Pitié, Paris (France)|
|Principal Investigator:||Mª Cruz Almaraz, MD||Hosp. Universitario Carlos Haya, Málaga (Spain)|
|Principal Investigator:||Xavier Luque, MD||Centro de Atención Primaria Alcover, Tarragona (Spain)|
|Principal Investigator:||José Vicente Vaquer, MD||Centro de Salud Petrer I, Alicante (Spain)|
|Principal Investigator:||Luis de Teresa, MD||Hosp. San Vicente de Raspeig, Alicante (Spain)|
|Principal Investigator:||Silvia Narejos, MD||Centro de Atención Primaria Centelles, Barcelona (Spain)|
|Principal Investigator:||Xavier Farrés, MD||Centro de Atención Primaria El Remei, Vic, Barcelona (Spain)|
|Principal Investigator:||José Miguel Martínez, MD||Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain)|