The objective was to evaluate whether the soluble fibre Plantago ovata (Po)-husk improves cardiovascular disease (CVD) risk biomarkers including low-density
lipoprotein cholesterol (LDL-C).
In a multi-centred, double-blind, placebo-controlled, parallel, randomised trial conducted
in primary care-clinics in Spain, France and Holland, mild-moderate hypercholesterolaemic
patients (age range: 43–67 years) received 14 g/d of Po-husk (n = 126) or placebo (microcrystalline-cellulose 14 g/d; n = 128) in a low saturated fat diet for 8 weeks. Subsequently, if LDL-C remained ≥3.35 mmol/L [130 mg/dL], participants proceeded with the fibre plus simvastatin (20 mg/d) for further 8 weeks. Lipid profile, blood pressure (BP), insulin, oxidised LDL
and some gene polymorphisms involved in CVD risk were measured.
Relative to placebo, Po-husk reduced plasma LDL-C by −6% (P < 0.0002), total cholesterol (TC) by −6%, triglycerides (TG) by −21.6%, apolipoprotein
(Apo) B-100 by −6.7%, oxidised LDL by a mean of −6.82 U/L (95%CI: 3.15–10.48), insulin by −4.68 pmol/L (95%CI: 0.68–8.67) and systolic BP by −4.0 mm Hg (95%CI; 1.2–6.7) (P < 0.05). The TG-lowering effect in the Po-husk group was magnified by variants in plasminogen-activator-inhibitor
(PAI-1; rs1799768) and fatty acid-binding protein (FABP-2; rs1799883) genes. At 16
weeks, the intra-group action of simvastatin (20 mg/d) added to Po-husk or placebo was a similar LDL-C reduction.
Po-husk, apart from lowering LDL-C, also reduced TG, TG related to certain gene variants,
TC, Apo B-100, oxLDL, insulin-resistance and systolic BP in mild-moderate hypercholesterolaemic
Thus, the target patients to receive Po-husk would be those who present a cluster
of various CVD risk factors, such as metabolic syndrome.