NCT03540108: ProLoChol

The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults.

Completed NA Last updated 27 April 2021

What this trial tests

NA trial testing Lactobacillus plantarum ECGC 13110402 in Hypercholesterolemia in 16 participants. Completed in 1 April 2021.

Timeline

1 February 2020

Primary endpoint
1 January 2021

1 April 2021

Quick facts

Lead sponsor	University of Roehampton
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	1 February 2020
Primary completion	1 January 2021
Estimated completion	1 April 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Lactobacillus plantarum ECGC 13110402
• Placebo Comparator: Maltodextrin

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

University of Roehampton

Who can join

Adults 35 to 70, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.