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

Phase 2

Completed

• Conditions: Cardiovascular Disease; Hypercholesterolemia

• Registration Number: NCT00502047
• Lead Sponsor: Rottapharm Spain

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.

Study Timeline

• Study Start: 2005-09
• Status Verified: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Last Update Submitted: 2007-07-16
• Study First Posted: 2007-07-17
• Last Update Posted: 2007-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hosp. Universitario San Joan de Reus, (Spain); 🇪🇸 Reus, Tarragona, Spain