The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults. (ProLoChol)
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|ClinicalTrials.gov Identifier: NCT03540108|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: Lactobacillus plantarum ECGC 13110402 Dietary Supplement: Placebo Comparator: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic Adults|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Experimental: L. plantarum ECGC 13110402 (LPLDL®)
Lactobacillus plantarum ECGC 13110402 (LPLDL®) 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 once a day, after lunch with 250mL of water.
Dietary Supplement: Lactobacillus plantarum ECGC 13110402
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: 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.
Dietary Supplement: Placebo Comparator: Maltodextrin
Please see intervention description above.
- 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.
- Digestive symptoms [ Time Frame: from baseline to 6 and 12 weeks of the intervention ]Bristol diary form Bristol diary form.
- Dietary assessment [ Time Frame: from baseline to 6 and 12 weeks of the intervention ]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.)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540108
|Contact: Adele Dr Costabile, PhD||+44 (0) 20 8392 firstname.lastname@example.org|