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

Primary Purpose

Hypercholesterolemia, Cardiovascular Disease

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Plantago ovata husk

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hosp. Universitario San Joan de Reus, (Spain)

Outcomes

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.

Secondary Outcome Measures

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

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

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)

Full Information

NCT ID

NCT00502047

First Posted

July 16, 2007

Last Updated

July 16, 2007

Sponsor

Rottapharm Spain

1. Study Identification

Unique Protocol Identification Number

NCT00502047

Brief Title

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

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rottapharm Spain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Cardiovascular Disease

Keywords

plantago ovata husk, soluble fibre, hypercholesterolemia, cardiovascular risk factor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

255 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Plantago ovata husk

Primary Outcome Measure Information:

Title

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

16 weeks

Title

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

Time Frame

16 weeks

Title

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials: