Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
This study has been completed.
Sponsor:
Rottapharm Spain
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
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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 |
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
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 May 23, 2013