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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2004-002184-24 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plantago ovata husk | Drug |
| Measure | Description | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Triglycerides >350 mg/dl
History of cardiovascular disease
Diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Solà, MD, phD | Hosp. Universitario San Joan de Reus , Spain | Study Chair |
| 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosp. Universitario San Joan de Reus, (Spain) | Reus | Tarragona | 43201 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23840361 | Derived | Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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 |
| Principal Investigator |
| José Miguel Martínez, MD | Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain) | Principal Investigator |
| D009750 |
| Nutritional and Metabolic Diseases |