A Phase 2/3 interventional study of Plantago ovata husk in Hypercholesterolemia and Cardiovascular Disease, sponsored by Rottapharm Spain. Completed at 1 site in Spain. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2007-07-17.
Sponsored by Rottapharm Spain · Phase 2/3, Interventional, and Treatment
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 255 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Rottapharm Spain is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of cardiovascular disease
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
To study the combined cholesterol lowering effect of treatment with Plantago ovata husk and statins to achieve the therapeutic objective
Time frame: 16 weeks
To analyse the effect of Plantago ovata husk fibre on blood pressure
Time frame: 16 weeks
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
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rottapharm Spain