The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum LPLDL® in Hypercholesterolemic Adults.

NCT03540108 | Completed DMC

• 1 other identifier: LSC 18/ 241
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia; bile acid synthesis; cholesterol; bile salt hydrolysis; vitamin D; probiotic L plantarum LPLDL®

Outcome Measures

Primary Outcomes (4)

• Cholesterol-lowering efficacy

  To test, in humans, whether the LPLDL® intervention lowers total cholesterol by a log change of min. 0.45 ± 0.4.

  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).

  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.

  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.

  from baseline to 6 and 12 weeks of the intervention

Secondary Outcomes (2)

• Digestive symptoms

  from baseline to 6 and 12 weeks of the intervention

• Dietary assessment

  from baseline to 6 and 12 weeks of the intervention

Study Arms (2)

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.

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.

Dietary Supplement: Placebo Comparator: Maltodextrin

Interventions

Lactobacillus plantarum ECGC 13110402 DIETARY_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).

Experimental: L. plantarum ECGC 13110402 (LPLDL®)

Placebo Comparator: Maltodextrin DIETARY_SUPPLEMENT

Please see intervention description above.

Placebo Comparator: Maltodextrin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females from 35 to 70 years of age
• BMI 18.5 to 29.9 kg/m2
• total cholesterol (TC) \>6mmol/L.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Adele Costabile, PhD

  University of Roehampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Nutrition

Model Details: 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).

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 30, 2018
• Study Start: February 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)