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

NCT ID: NCT00502047

Last Updated: 2007-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Plantago ovata husk

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rottapharm Spain

INDUSTRY

Sponsor Role lead

Principal Investigators

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Rosa Solà, MD, phD

Role: STUDY_CHAIR

Hosp. Universitario San Joan de Reus , Spain

Manuel Castro, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands)

Eric Brucker, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Hosp. de la Pitié, Paris (France)

Mª Cruz Almaraz, MD

Role: PRINCIPAL_INVESTIGATOR

Hosp. Universitario Carlos Haya, Málaga (Spain)

Xavier Luque, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Atención Primaria Alcover, Tarragona (Spain)

José Vicente Vaquer, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Salud Petrer I, Alicante (Spain)

Luis de Teresa, MD

Role: PRINCIPAL_INVESTIGATOR

Hosp. San Vicente de Raspeig, Alicante (Spain)

Silvia Narejos, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Atención Primaria Centelles, Barcelona (Spain)

Xavier Farrés, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Atención Primaria El Remei, Vic, Barcelona (Spain)

José Miguel Martínez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain)

Locations

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Hosp. Universitario San Joan de Reus, (Spain)

Reus, Tarragona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 23840361 (View on PubMed)

Other Identifiers

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EudraCT number: 2004-002184-24

Identifier Type: -

Identifier Source: secondary_id

PLAN-EC-HIPERL-02

Identifier Type: -

Identifier Source: org_study_id