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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502047
• Other study ID #: PLAN-EC-HIPERL-02
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 16, 2007
• Last updated: July 16, 2007
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

Drug:
• Plantago ovata husk

Locations

Country	Name	City	State
Spain	Hosp. Universitario San Joan de Reus, (Spain)	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective		16 weeks
Secondary	To analyse the effect of Plantago ovata husk fibre on blood pressure		16 weeks
Secondary	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