Clinical trial NCT00502047: Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypercholesterolemia
Cardiovascular Disease
Keywords: plantago ovata husk
soluble fibre
hypercholesterolemia
cardiovascular risk factor
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
measure: To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective
timeFrame: 16 weeks
measure: To analyse the effect of Plantago ovata husk fibre on blood pressure
timeFrame: 16 weeks
measure: 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)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hosp. Universitario San Joan de Reus, (Spain)
state: Tarragona
Study officials:
affiliation: Hosp. Universitario San Joan de Reus , Spain
name: Rosa Solà, MD, phD
role: STUDY_CHAIR
affiliation: Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)
name: Manuel Castro, MD, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. de la Pitié, Paris (France)
name: Eric Brucker, MD, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Universitario Carlos Haya, Málaga (Spain)
name: Mª Cruz Almaraz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Atención Primaria Alcover, Tarragona (Spain)
name: Xavier Luque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Salud Petrer I, Alicante (Spain)
name: José Vicente Vaquer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. San Vicente de Raspeig, Alicante (Spain)
name: Luis de Teresa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Atención Primaria Centelles, Barcelona (Spain)
name: Silvia Narejos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Atención Primaria El Remei, Vic, Barcelona (Spain)
name: Xavier Farrés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain)
name: José Miguel Martínez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.