Cardiovascular Disease, Hypercholesterolemia
Conditions
Keywords
plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor
Brief summary
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
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.
Interventions
Sponsors
Rottapharm Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed