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OpenTrials
Completed

NCT Number: NCT00502047

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hosp. Universitario San Joan de Reus, (Spain)

Reus, Tarragona, 43201, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plantago ovata husk

Drug

Primary outcomes

  1. 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 outcomes

  1. To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective

    Time frame: 16 weeks

  2. To analyse the effect of Plantago ovata husk fibre on blood pressure

    Time frame: 16 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

Rottapharm Spain

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Jul 17, 2007
Registry last updated
Jul 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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