- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540108
The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults. (ProLoChol)
April 26, 2021 updated by: DR ADELE COSTABILE, University of Roehampton
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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UK
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London, UK, United Kingdom, SW15 4JD
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males and females from 35 to 70 years of age
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) >6mmol/L.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: L. plantarum ECGC 13110402 (LPLDL®)
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.
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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).
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Placebo Comparator: Placebo Comparator: Maltodextrin
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.
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Please see intervention description above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cholesterol-lowering efficacy
Time Frame: from baseline to 6 and 12 weeks of the intervention
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To test, in humans, whether the LPLDL® intervention lowers total cholesterol by a log change of min.
0.45 ± 0.4.
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from baseline to 6 and 12 weeks of the intervention
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Effect on the gut microbiota
Time Frame: from baseline to 6 and 12 weeks of the intervention
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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).
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from baseline to 6 and 12 weeks of the intervention
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Effect on vitamin D absorption and ABOB
Time Frame: from baseline to 6 and 12 weeks of the intervention
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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.
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from baseline to 6 and 12 weeks of the intervention
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Effect on bile acid metabolism
Time Frame: from baseline to 6 and 12 weeks of the intervention
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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.
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from baseline to 6 and 12 weeks of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digestive symptoms
Time Frame: from baseline to 6 and 12 weeks of the intervention
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Bristol diary form Bristol diary form.
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from baseline to 6 and 12 weeks of the intervention
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Dietary assessment
Time Frame: from baseline to 6 and 12 weeks of the intervention
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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.)
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from baseline to 6 and 12 weeks of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Adele Costabile, PhD, University of Roehampton
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
May 25, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSC 18/ 241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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