NCT07519967

Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids

A 12-week, Randomised, Double-blinded, Placebo Controlled Study to Evaluate the Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids and Cholesterol in Healthy Mildly Hypercholesterolaemic (≥5.5mmol/L and <8 mmol/L) Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Cardiovascular disease (CVD) is the leading cause of death and morbidity in the EU. Among the recommendations to avoid heart disease is the maintenance of normal blood cholesterol levels, by ingesting a cardioprotective diet and if necessary via the use of drugs such as statins. Low consumer compliance with dietary recommendations and the expense and side effects of drug therapy for many consumers, aligned with increased consumer acceptance of foods with additional health benefits has led to an opportunity for functional foods in the heart health area. The global market for foods with heart health benefits in the US, UK, Germany, France, Spain, Italy, Japan and Australia in 2009 was €10.84 billion (Leatherhead Food International). In apilot study in 10 mildly hypercholesterolaemic (≥5mmol/L and \<7.5mmol/L) male adults, who were administered Lb. mucosae DPC6426 daily for 6 weeks, resulted in an increase in ratio of HDL to total cholesterol from start to end of the study. Therefore, this Lactobacillus mucosae strain may lead to the development of novel functional foods and supplements with potential cardioprotective properties. Lb. mucosae DPC 6426 was benchmarked against plant sterol-esters, oat beta glucan and other probiotics strains (Lb. reuterii, NCIMB 30242) and was found to be more effective than oat beta glucan and Lb. reuterii, and similar in its effect on cholesterol as plant sterol esters. Subjects were invited to participate in this study as they gad hypercholesterolaemia (defined as cholesterol between 5.5 mmol/L and 7.9 mmol/L) The duration of your participation in this study is approximately 15-17 consecutive weeks.

Conditions

• Cholesterol
• Hypercholesterolaemia

Interventions

Type	Name	Description
OTHER	Placebo	an identical capsule without Lb. mucosae DPC6426.
OTHER	Lactobacillus mucosae DPC6426	Lactobacillus mucosae DPC6426

Timeline

• Start date: 2016-05-30
• Primary completion: 2017-01-18
• Completion: 2017-01-18
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Ireland