The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults

NCT03263104 | Completed DMC

• 1 other identifier: UREC 15/06
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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 was to test whether probiotics can directly degrade cholesterol as well as produce metabolites that interfere with its synthesis in the liver. The effect may also be partially ascribed to an enzymatic deconjugation of bile acids.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402

  Effects of the probiotic on TC, LDL-C, HDL-C and TAG

  Changes from baseline to 6-12 week treatment period with the probiotic

Secondary Outcomes (1)

• Modulation of immune function by L. plantarum ECGC 13110402

  Changes from baseline to 6-12 week treatment period with the probiotic

Other Outcomes (2)

• Digestive symptoms

  Changes from baseline to 6-12 week treatment period with the probiotic

• Microbiota changes

  Changes from baseline to 6-12 week treatment period with the probiotic

Study Arms (2)

Lactobacillus plantarum ECGC 13110402

EXPERIMENTAL

Lactobacillus plantarum ECGC 13110402 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 twice daily, before breakfast and dinner with 250mL of water.

Dietary Supplement: Lactobacillus plantarum ECGC 13110402

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 twice daily, before breakfast and dinner with 250mL of water.

Dietary Supplement: Maltodextrin

Interventions

Lactobacillus plantarum ECGC 13110402 DIETARY_SUPPLEMENT

Lactobacillus plantarum ECGC 13110402

Lactobacillus plantarum ECGC 13110402

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 18 and 50 years of age.
• in good general health, defined as no comorbidities requiring regular
• medical follow up
• ability to communicate well with the investigator and to comply with the
• requirements of the entire study
• BMI 18.5 to 29.9 kg/m2
• total cholesterol (TC) between 200 and 300 mg/dl (5.16 and 7.64 mmol/L).

You may not qualify if:

• History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
• Consumed probiotic or prebiotic preparations on a regular basis (at least 3
• times per week) in the last 2 weeks and during the trial period
• Former participation in another study involving prebiotic or probiotic
• preparations or investigational drugs within the previous 6 months, or
• intention to use such drugs during the course of the study
• high blood cholesterol or use of cholesterol lowering drugs
• Undergone surgical resection of any part of the bowel
• History of malignancy within the previous 5 years (with exception of well-
• treated basal cell carcinoma or in situ cervical carcinoma).
• Currently prescribed immunosuppressive drugs
• Intention to use regularly other medication which affects gastrointestinal
• motility and/or perception
• Current or recent history (within 12 months) of significant drug or alcohol
• abuse or dependence

Sponsors & Collaborators

• University of Roehampton: lead

Related Publications (1)

• Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.

  PMID: 29228000 DERIVED

MeSH Terms

Interventions

maltodextrin

Study Officials

• Glenn R Gibson

  The University of Reading

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (Participant, Investigator,Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Research Centre, Life Science Department

Model Details: Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 28, 2017
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share