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

July 16, 2007 updated by: Rottapharm Spain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Reus, Tarragona, Spain, 43201
        • Hosp. Universitario San Joan de Reus, (Spain)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rottapharm Spain

Investigators

  • Study Chair: Rosa Solà, MD, phD, Hosp. Universitario San Joan de Reus , Spain
  • Principal Investigator: Manuel Castro, MD, phD, Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)
  • Principal Investigator: Eric Brucker, MD, phD, Hosp. de la Pitié, Paris (France)
  • Principal Investigator: Mª Cruz Almaraz, MD, Hosp. Universitario Carlos Haya, Málaga (Spain)
  • Principal Investigator: Xavier Luque, MD, Centro de Atención Primaria Alcover, Tarragona (Spain)
  • Principal Investigator: José Vicente Vaquer, MD, Centro de Salud Petrer I, Alicante (Spain)
  • Principal Investigator: Luis de Teresa, MD, Hosp. San Vicente de Raspeig, Alicante (Spain)
  • Principal Investigator: Silvia Narejos, MD, Centro de Atención Primaria Centelles, Barcelona (Spain)
  • Principal Investigator: Xavier Farrés, MD, Centro de Atención Primaria El Remei, Vic, Barcelona (Spain)
  • Principal Investigator: José Miguel Martínez, MD, Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

July 17, 2007

Last Update Submitted That Met QC Criteria

July 16, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAN-EC-HIPERL-02
  • EudraCT number: 2004-002184-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Plantago ovata husk

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe