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The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults

NCT03263104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-08-28

No results posted yet for this study

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 was to test whether probiotics can directly degrade cholesterol as well as produce metabolites that interfere with its synthesis in the liver. The effect may also be partially ascribed to an enzymatic deconjugation of bile acids.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum ECGC 13110402

Lactobacillus plantarum ECGC 13110402

DIETARY_SUPPLEMENT

Maltodextrin

Sponsors & Collaborators

  • University of Roehampton

    lead OTHER

Principal Investigators

  • Glenn R Gibson · The University of Reading

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263104 on ClinicalTrials.gov