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NCT Number: NCT03540108

The Efficacy of Cholesterol-lowering Probiotic Lactobacillus Plantarum 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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, UK, SW15 4JD, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Placebo Comparator: Maltodextrin

Dietary Supplement

Please see intervention description above.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. Digestive symptoms

    Time frame: from baseline to 6 and 12 weeks of the intervention

    Bristol diary form Bristol diary form.

  2. 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.)

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study title

The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum ECGC 13110402 (LPLDL®) in Hypercholesterolemic Adults

Acronym: ProLoChol

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 30, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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