Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Cardiovascular Disease

Intervention / Treatment
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* Drug: Plantago ovata husk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Levels of LDL-c between >130 mg/dl and <189 mg/dl Presence at least 1 of the cardiovascular risk factor defined as: age above 45 years in men and 55 years in women smoker high blood pressure HDL-c < 40 mg/dl in men and <46 mg/dl in women family background of early heart disease Patients who have given informed consent Patients who will be capable of following diet guidelines Exclusion Criteria: Triglycerides >350 mg/dl History of cardiovascular disease treatment with statins prior to the beginning of the trial and who have not dropped out at least 2 months before the beginning of the study Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Plantago ovata husk|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective |  | 16 weeks | 
| To analyse the effect of Plantago ovata husk fibre on blood pressure |  | 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) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor