The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults.
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Coronary heart disease (CHD) is one of the major causes of death and disability in
      industrialised countries. Results from several epidemiological and clinical studies indicate
      a positive correlation between elevated total serum cholesterol levels, mainly reflecting the
      LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma
      cholesterol levels in populations suffering from primary hypercholesterolemia (elevated
      cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is
      extensive interest in the management of serum cholesterol and other blood lipids. Diet is
      viewed as a major influencing factor that can reduce levels. This is largely driven by the
      expense of drug therapy, the large numbers of individuals affected and unwanted side effects
      of such treatments. Dietary strategies for prevention of CHD implicate adherence to a
      low-fat/low-saturated fat diet. Although such diets may present an effective approach, they
      are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,
      new approaches towards identification of other dietary means of reducing blood cholesterol
      levels have been evaluated. These include, among others, the use of probiotics. Probiotics
      are 'live microbial feed supplements that offer a benefit to health'. They are marketed as
      health or functional foods whereby they are ingested for their purported positive advantages
      in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main
      goal of the study is to test the efficacy of the probiotic in degrading cholesterol as well
      as produce metabolites that interfere with its synthesis in the liver in adults with high
      cholesterol (>6mmol). The effect may also be partially ascribed to an enzymatic deconjugation
      of bile acids.
    

Detailed description: 
      The aim of this human volunteer study is to establish the extent of extent of the cholesterol
      lowering potential of Lactobacillus plantarum ECGC 13110402 in 50 hypercholesterolaemic
      adults (35-70 years old).
    

Intervention name(s): Lactobacillus plantarum ECGC 13110402; Placebo Comparator: Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study will consist of two phases: a treatment period (12 weeks) with either the active or placebo and a wash-out period (4 weeks). Following a screening visit to ensure adherence to the inclusion criteria, the study will consist of a baseline, midpoint, endpoint (week 6 and 12, respectively) and washout visit (week 16).; Please see intervention description above.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 (LPLDL® in hypercholesterolaemic adults (>6mmol).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; bile acid synthesis; cholesterol; bile salt hydrolysis; vitamin D; probiotic L plantarum LPLDL®