Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids (NCT07519967) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids
Ireland94 participantsStarted 2016-05-30
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be able to give written informed consen
. Be between 20 and 70 years of age,
. Subjects are mildly hypercholesterolaemic, with a total cholesterol level \>5.5 mmol/L and \<8mmol/L,
. Subject has a BMI of between 18.5 - 32 Kg/m2,
. Have a stable body weight (\< 5% change) over the past 3-months, -Subject is in general good health as determined by the investigator.
Exclusion criteria
. Are less than 20 and greater than 70 years of age,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
. Subject is a smoker,
. Are hypersensitive to any of the components of the test product,
. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
. Subject is taking a probiotic or prebiotic product/supplement or have taken them within two weeks of the screening visit,
. Subject has received a blood transfusion within the previous 6 months,
. Subjects has taken antibiotics within the previous 3 months,