Clinical trial NCT03540108: The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults.
Official title: The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
bile acid synthesis
cholesterol
bile salt hydrolysis
vitamin D
probiotic L plantarum LPLDL®
Lead sponsor: University of Roehampton
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* males and females from 35 to 70 years of age
* BMI 18.5 to 29.9 kg/m2
* total cholesterol (TC) \>6mmol/L.

Exclusion Criteria:

* suffering from chronic gastrointestinal complaints (including chronic constipation, diarrhoea or Irritable Bowel Syndrome)
* diabetes or anaemia
* requirement to take long-term medications active on the gastrointestinal tract, treatment of cardio-vascular disease, or any other long-term medication
* high blood cholesterol or use of cholesterol lowering drugs/ functional foods
* history of drug or alcohol misuse or alcohol consumption exceeding 14 and 21 units/week for females and males respectively
* those suffering with any allergies to medication or food
* on weight-reducing diets.
* Females planning pregnancy within six months from the start of the study, lactating, or have given birth within the preceding six months
* use of antibiotics within six months preceding the study, participation in any probiotic, prebiotic or laxative study or intake of an experimental drug four weeks prior to the study start.
* Individuals exercising \> 16 744 kJ per week

Primary outcomes:
measure: Cholesterol-lowering efficacy
timeFrame: from baseline to 6 and 12 weeks of the intervention
measure: Effect on the gut microbiota
timeFrame: from baseline to 6 and 12 weeks of the intervention
measure: Effect on vitamin D absorption and ABOB
timeFrame: from baseline to 6 and 12 weeks of the intervention
measure: Effect on bile acid metabolism
timeFrame: from baseline to 6 and 12 weeks of the intervention
Secondary outcomes:
measure: Digestive symptoms
timeFrame: from baseline to 6 and 12 weeks of the intervention
measure: Dietary assessment
timeFrame: from baseline to 6 and 12 weeks of the intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton
state: UK
Study officials:
affiliation: University of Roehampton
name: Adele Costabile, PhD
role: STUDY_DIRECTOR
References: