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

This study has been completed.
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00502047
First received: July 16, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Cardiovascular Disease
Drug: Plantago ovata husk
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 255
Study Start Date: September 2005
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502047

Locations
Spain
Hosp. Universitario San Joan de Reus, (Spain)
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502047     History of Changes
Other Study ID Numbers: PLAN-EC-HIPERL-02, EudraCT number: 2004-002184-24
Study First Received: July 16, 2007
Last Updated: July 16, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm Spain:
plantago ovata husk
soluble fibre
hypercholesterolemia
cardiovascular risk factor

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014