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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540108
|Contact: Adele Dr Costabile, PhD||+44 (0) 20 8392 email@example.com|