Coronary heart disease (CHD) is one of the major causes of death and disability in industrialised countries. The World Health Organization (WHO) predicts that by the year 2020, up to 40% of all human deaths will be related to cardiovascular diseases. Results from epidemiological and clinical studies indicate a positive correlation between elevated total serum cholesterol levels, mainly reflecting the low density lipoprotein-cholesterol fraction (LDL-C), and risk of CHD onset.
The aim of this human volunteer study was to establish tolerance, and the extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy, normal to mildly hypercholesterolaemic adults (30–65 years old). Primary efficacy outcomes included the effect on blood lipids (total cholesterol, TC; low density lipoproteins, LDL-C; high density lipoproteins, HDL-C; and triacylgycerides, TAG), inflammatory biomarkers and the occurrence/ severity of gastrointestinal side effects to establish the safety and tolerance of the intervention. Secondary outcomes included blood pressure, immune biomarkers, gut microbiota characterisation and metabonome changes. The 12-week intervention was conducted in a parallel, double blind, placebo controlled, randomised design and concluded with a four-week washout period.
Outcomes and Impact
The results of this study demonstrated statistically significant effects across a number of CHD risk factors, particularly LDL, HDL, and blood pressure in normal to mildly hypercholesterolaemic subjects.
The study was designed to explore effects across a broad healthy population and was not targeted at a high cholesterol group to demonstrate clinical efficacy. It is believed that optimisation of the study protocol, dosage timing, and targeting a higher cholesterol population and/or high blood pressure group and potentially combination with a Lactobacillus plantarum targeted prebiotic may further enhance and demonstrate the cholesterol lowering activity in vivo.
Key university staff
Professor Glenn Gibson, Professor of Food Microbiology, Head of Food Microbial Sciences, School of Chemistry, Food & Pharmacy, University of Reading