HealthyPROBIOCHOLNCT03263104
The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults
A study testing Lactobacillus plantarum ECGC 13110402 and Maltodextrin in people with Healthy, run by University of Roehampton.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus plantarum ECGC 13110402 and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 18 and 50 years of age.
- in good general health, defined as no comorbidities requiring regular
- medical follow up
- ability to communicate well with the investigator and to comply with the
- requirements of the entire study
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) between 200 and 300 mg/dl (5.16 and 7.64 mmol/L).
Who cannot join
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3
- times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic
- preparations or investigational drugs within the previous 6 months, or
- intention to use such drugs during the course of the study
Show all 15Show fewer
- high blood cholesterol or use of cholesterol lowering drugs
- Undergone surgical resection of any part of the bowel
- History of malignancy within the previous 5 years (with exception of well-
- treated basal cell carcinoma or in situ cervical carcinoma).
- Currently prescribed immunosuppressive drugs
- Intention to use regularly other medication which affects gastrointestinal
- motility and/or perception
- Current or recent history (within 12 months) of significant drug or alcohol
- abuse or dependence
About this study
Official title: Single-centre, Prospective, Randomised, Placebo-controlled, Parallel-group Design to Determine the Cholesterol-lowering Efficacy of Lactobacillus Plantarum ECGC 13110402 in Normal to Mildly Hypercholesterolaemic Adults
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.
Read the detailed description
The aim of this human volunteer study was to establish tolerance, and the extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy, normal to mildly hypercholesterolaemic adults (30-65 years old).
- Conditions
- Healthy
- Being tested
- Lactobacillus plantarum ECGC 13110402, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum ECGC 13110402Dietary supplement
Lactobacillus plantarum ECGC 13110402
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum ECGC 13110402 | Experimental | Lactobacillus plantarum ECGC 13110402 equivalent to 2x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water. Receives: Dietary Supplement: Lactobacillus plantarum ECGC 13110402 |
| Maltodextrin | Placebo comparator | Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402
Effects of the probiotic on TC, LDL-C, HDL-C and TAG
Measured: Changes from baseline to 6-12 week treatment period with the probiotic
Secondary outcomes (1)
Modulation of immune function by L. plantarum ECGC 13110402
Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production
Measured: Changes from baseline to 6-12 week treatment period with the probiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study startJan 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Glenn R Gibson, Study director, The University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263104
- Sponsor's protocol ID
- UREC 15/06
- Acronym
- PROBIOCHOL
- Status last verified
- Aug 2017
- First submitted
- 17 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.
PubMed 29228000
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Prospective, Randomised, Placebo-controlled, Parallel-group Design to Determine the Cholesterol-lowering Efficacy of Lactobacillus Plantarum ECGC 13110402 in Normal to Mildly Hypercholesterolaemic Adults
- ClinicalTrials.gov ID
- NCT03263104
- Acronym / sponsor ID
- PROBIOCHOL / UREC 15/06
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Aug 2017 (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.
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.
Detailed description
The aim of this human volunteer study was to establish tolerance, and the extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy, normal to mildly hypercholesterolaemic adults (30-65 years old).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum ECGC 13110402 | Experimental | Dietary Supplement: Lactobacillus plantarum ECGC 13110402Lactobacillus plantarum ECGC 13110402 equivalent to 2x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- aged between 18 and 50 years of age.
- in good general health, defined as no comorbidities requiring regular
- medical follow up
- ability to communicate well with the investigator and to comply with the
- requirements of the entire study
Key exclusion criteria (15 listed)
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3
- times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic
- preparations or investigational drugs within the previous 6 months, or
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 |
|---|---|---|
| Lactobacillus plantarum ECGC 13110402Lactobacillus plantarum ECGC 13110402 | Dietary supplement | Lactobacillus plantarum ECGC 13110402 |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402
Time frame: Changes from baseline to 6-12 week treatment period with the probiotic
Effects of the probiotic on TC, LDL-C, HDL-C and TAG
1 secondary outcome
Modulation of immune function by L. plantarum ECGC 13110402
Time frame: Changes from baseline to 6-12 week treatment period with the probiotic
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 28 Aug 2017.
- Derived from this study: PubMed 29228000Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Glenn R Gibson study director
The University of Reading
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum ECGC 13110402 and Maltodextrin in people with Healthy, run by University of Roehampton.
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 7 inclusion and 15 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402 (time frame: Changes from baseline to 6-12 week treatment period with the probiotic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263104, which also lists 1 linked publication.
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 28 Aug 2017.