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

Rottapharm

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hypercholesterolemia

Cardiovascular Disease

Treatments

Drug: Plantago ovata husk

Study type

Interventional

Funder types

Industry

Identifiers

NCT00502047

EudraCT number: 2004-002184-24

PLAN-EC-HIPERL-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

255 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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