CholesterolNCT07519967
Efficacy of Lactobacillus Mucosae DPC6426 on Blood-lipids
A study testing Lactobacillus mucosae DPC6426 in people with Cholesterol and Hypercholesterolaemia, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol, Hypercholesterolaemia
- What is being tested?
- Lactobacillus mucosae DPC6426
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteIreland
- Study dates
- 30 May 2016to 18 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are less than 20 and greater than 70 years of age,
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication), v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
- Subject is a smoker,
- Are hypersensitive to any of the components of the test product,
Show all 13Show fewer
- 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,
- Subject has a history of drug and/or alcohol abuse at the time of enrolment,
- Have a Gamma-GT outside the normal range,
- Have an active gastrointestinal disorder or previous gastrointestinal surgery,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read more
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
- Being tested
- Placebo, Lactobacillus mucosae DPC6426
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
an identical capsule without Lb. mucosae DPC6426.
Lactobacillus mucosae DPC6426Other
Lactobacillus mucosae DPC6426
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus mucosae DPC6426 | Experimental | Lactobacillus mucosae DPC6426 Receives: Other: Lactobacillus mucosae DPC6426 |
| Placebo | Sham comparator | an identical capsule without Lb. mucosae DPC6426. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in total cholesterol, from baseline to week 12, in mildly hypercholesterolaemic (> 5.5 mmol/L and < 8mmol/L) adults.
Measured: Baseline to Week 12
Secondary outcomes (5)
Total cholesterol
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in total cholesterol, from baseline to weeks 4 and 8, in mildly hypercholesterolaemic (> 5mmol/L and < 8mmol/L) adults
Measured: Baseline to Week 4 and Week 8
LDL-cholesterol
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in LDL-cholesterol concentrations, from baseline to weeks 4, 8 \& 12, in mildly hypercholesterolaemic (> 5mmol/L and < 8mmol/L) adults.
Measured: Baseline to Week 4, Week 8 and Week 12
HDL-cholesterol
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in HDL-cholesterol concentrations, from baseline to weeks 4, 8 \& 12, in mildly hypercholesterolaemic (> 5mmol/L and < 8mmol/L) adults.
Measured: Baseline to Week 4 Week 8 and Week 12
Triglycerides
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in triglycerides concentrations, from baseline to weeks 4, 8 \& 12, in mildly hypercholesterolaemic (> 5mmol/L and < 8mmol/L) adults.
Measured: Baseline to Week 4, Week 8 and Week 12
Adverse events
To evaluate the safety of Lactobacillus mucosae DPC6426, relative to placebo, in terms of the occurrence of adverse events in mildly hypercholesterolaemic (> 5.5mmol/L and < 8mmol/L) adults.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 May 2016
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blinded, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Noel Caplice, University College Cork
- Investigators
- Prof. Noel Caplice, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519967
- Sponsor's protocol ID
- AFCRO-059
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07519967
- Acronym / sponsor ID
- AFCRO-059
- Conditions
- Cholesterol, Hypercholesterolaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blinded, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus mucosae DPC6426 | Experimental | Other: Lactobacillus mucosae DPC6426Lactobacillus mucosae DPC6426 |
| Placebo | Sham comparator | Other: Placeboan identical capsule without Lb. mucosae DPC6426. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Are less than 20 and greater than 70 years of age,
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboan identical capsule without Lb. mucosae DPC6426. | Other | Placebo |
| Lactobacillus mucosae DPC6426Lactobacillus mucosae DPC6426 | Other | Lactobacillus mucosae DPC6426 |
Primary outcome
Total cholesterol
Time frame: Baseline to Week 12
To compare the effect of Lactobacillus mucosae DPC6426, relative to placebo, on changes in total cholesterol, from baseline to week 12, in mildly hypercholesterolaemic (> 5.5 mmol/L and < 8mmol/L) adults.
5 secondary outcomes
Total cholesterol
Time frame: Baseline to Week 4 and Week 8
LDL-cholesterol
Time frame: Baseline to Week 4, Week 8 and Week 12
HDL-cholesterol
Time frame: Baseline to Week 4 Week 8 and Week 12
Triglycerides
Time frame: Baseline to Week 4, Week 8 and Week 12
Adverse events
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Noel Caplice principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus mucosae DPC6426 in people with Cholesterol and Hypercholesterolaemia, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.