HypercholesterolemiaProLoCholNCT03540108
The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults.
A study testing Lactobacillus plantarum ECGC 13110402 in people with Hypercholesterolemia, run by University of Roehampton at 1 site in United Kingdom.
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 35 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lactobacillus plantarum ECGC 13110402
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2020to 1 Apr 2021
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females from 35 to 70 years of age
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) >6mmol/L.
Who cannot join
- suffering from chronic gastrointestinal complaints (including chronic constipation, diarrhoea or Irritable Bowel Syndrome)
- diabetes or anaemia
- requirement to take long-term medications active on the gastrointestinal tract, treatment of cardio-vascular disease, or any other long-term medication
- high blood cholesterol or use of cholesterol lowering drugs/ functional foods
- history of drug or alcohol misuse or alcohol consumption exceeding 14 and 21 units/week for females and males respectively
- those suffering with any allergies to medication or food
Show all 10Show fewer
- on weight-reducing diets.
- Females planning pregnancy within six months from the start of the study, lactating, or have given birth within the preceding six months
- use of antibiotics within six months preceding the study, participation in any probiotic, prebiotic or laxative study or intake of an experimental drug four weeks prior to the study start.
- Individuals exercising > 16 744 kJ per week
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic 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 is to test the efficacy of the probiotic in degrading cholesterol as well as produce metabolites that interfere with its synthesis in the liver in adults with high cholesterol (>6mmol). 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 is to establish the extent of extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 50 hypercholesterolaemic adults (35-70 years old).
- Conditions
- Hypercholesterolemia
- Being tested
- Lactobacillus plantarum ECGC 13110402, Placebo Comparator: Maltodextrin
- Keywords
- hypercholesterolemia, bile acid synthesis, cholesterol, bile salt hydrolysis, vitamin D, probiotic L plantarum LPLDL®
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum ECGC 13110402Dietary supplement
The study will consist of two phases: a treatment period (12 weeks) with either the active or placebo and a wash-out period (4 weeks). Following a screening visit to ensure adherence to the inclusion criteria, the study will consist of a baseline, midpoint, endpoint (week 6 and 12, respectively) and washout visit (week 16).
Placebo Comparator: MaltodextrinDietary supplement
Please see intervention description above.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: L. plantarum ECGC 13110402 (LPLDL®) | Experimental | Lactobacillus plantarum ECGC 13110402 (LPLDL®) equivalent to 4 x10^9 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 once a day, after lunch with 250mL of water. Receives: Dietary Supplement: Lactobacillus plantarum ECGC 13110402 |
| Placebo Comparator: 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 once a day, after lunch with 250mL of water. Receives: Dietary Supplement: Placebo Comparator: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol-lowering efficacy
To test, in humans, whether the LPLDL® intervention lowers total cholesterol by a log change of min. 0.45 ± 0.4.
Measured: from baseline to 6 and 12 weeks of the intervention
Effect on the gut microbiota
To determine the effect of LPLDL® on the faecal microbiota composition and microbial activity of the volunteers using DNA profiling from faeces (16s rRNA sequencing using Illumina MiSeq Platform and QIIME data analysis software).
Measured: from baseline to 6 and 12 weeks of the intervention
Effect on vitamin D absorption and ABOB
To investigate the effect of LPLDL® on vitamin D absorption in the study population by measuring circulating vitamin D in blood using clinical chemistry and monitoring vitamin D intake from food diary.
Measured: from baseline to 6 and 12 weeks of the intervention
Effect on bile acid metabolism
To assess any changes in bile acid metabolites and TMAO during the study trial using high performance liquid chromatography tandem mass spectrometry to analyse the urine samples.
Measured: from baseline to 6 and 12 weeks of the intervention
Secondary outcomes (2)
Digestive symptoms
Bristol diary form Bristol diary form.
Measured: from baseline to 6 and 12 weeks of the intervention
Dietary assessment
To conduct an assessment of dietary intake in the study population using a validated four-day food diary and dietplan 7 dietary analysis software (Forestfield Ltd.)
Measured: from baseline to 6 and 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Feb 2020
- Primary completion1 Jan 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- 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 (LPLDL® in hypercholesterolaemic adults (\>6mmol).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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
- Adele Costabile, PhD, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540108
- Sponsor's protocol ID
- LSC 18/ 241
- Acronym
- ProLoChol
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic Adults
- ClinicalTrials.gov ID
- NCT03540108
- Acronym / sponsor ID
- ProLoChol / LSC 18/ 241
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, bile acid synthesis, cholesterol, bile salt hydrolysis, vitamin D, probiotic L plantarum LPLDL®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 May 2018 (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 is to test the efficacy of the probiotic in degrading cholesterol as well as produce metabolites that interfere with its synthesis in the liver in adults with high cholesterol (>6mmol). The effect may also be partially ascribed to an enzymatic deconjugation of bile acids.
Detailed description
The aim of this human volunteer study is to establish the extent of extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 50 hypercholesterolaemic adults (35-70 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 (LPLDL® in hypercholesterolaemic adults (>6mmol).
| Arm | Type | Receives |
|---|---|---|
| Experimental: L. plantarum ECGC 13110402 (LPLDL®) | Experimental | Dietary Supplement: Lactobacillus plantarum ECGC 13110402Lactobacillus plantarum ECGC 13110402 (LPLDL®) equivalent to 4 x10^9 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 once a day, after lunch with 250mL of water. |
| Placebo Comparator: Maltodextrin | Placebo comparator | Dietary Supplement: Placebo Comparator: 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 once a day, after lunch with 250mL of water. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females from 35 to 70 years of age
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) >6mmol/L.
Key exclusion criteria (10 listed)
- suffering from chronic gastrointestinal complaints (including chronic constipation, diarrhoea or Irritable Bowel Syndrome)
- diabetes or anaemia
- requirement to take long-term medications active on the gastrointestinal tract, treatment of cardio-vascular disease, or any other long-term medication
- high blood cholesterol or use of cholesterol lowering drugs/ functional foods
- history of drug or alcohol misuse or alcohol consumption exceeding 14 and 21 units/week for females and males respectively
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 13110402The study will consist of two phases: a treatment period (12 weeks) with either the active or placebo and a wash-out period (4 weeks). Following a screening visit to ensure adherence to the inclusion criteria, the study will consist of a baseline, midpoint, endpoint (week 6 and 12, respectively) and washout visit (week 16). | Dietary supplement | Experimental: L. plantarum ECGC 13110402 (LPLDL®) |
| Placebo Comparator: MaltodextrinPlease see intervention description above. | Dietary supplement | Placebo Comparator: Maltodextrin |
Primary outcome
Cholesterol-lowering efficacy
Time frame: from baseline to 6 and 12 weeks of the intervention
To test, in humans, whether the LPLDL® intervention lowers total cholesterol by a log change of min. 0.45 ± 0.4.
Effect on the gut microbiota
Time frame: from baseline to 6 and 12 weeks of the intervention
To determine the effect of LPLDL® on the faecal microbiota composition and microbial activity of the volunteers using DNA profiling from faeces (16s rRNA sequencing using Illumina MiSeq Platform and QIIME data analysis software).
Effect on vitamin D absorption and ABOB
Time frame: from baseline to 6 and 12 weeks of the intervention
To investigate the effect of LPLDL® on vitamin D absorption in the study population by measuring circulating vitamin D in blood using clinical chemistry and monitoring vitamin D intake from food diary.
Effect on bile acid metabolism
Time frame: from baseline to 6 and 12 weeks of the intervention
To assess any changes in bile acid metabolites and TMAO during the study trial using high performance liquid chromatography tandem mass spectrometry to analyse the urine samples.
2 secondary outcomes
Digestive symptoms
Time frame: from baseline to 6 and 12 weeks of the intervention
Dietary assessment
Time frame: from baseline to 6 and 12 weeks of the intervention
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 27 Apr 2021.
- 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.
Adele Costabile, PhD study director
University of Roehampton
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 plantarum ECGC 13110402 in people with Hypercholesterolemia, run by University of Roehampton at 1 site in United Kingdom.
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 3 inclusion and 10 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 27 Apr 2021. 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 United Kingdom. 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?
Cholesterol-lowering efficacy (time frame: from baseline to 6 and 12 weeks of the intervention). The study lists 4 primary outcomes in all. 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 27 Apr 2021.