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

• ClinicalTrials.gov Identifier: NCT03263104
• Recruitment Status: Completed
• First Posted: August 28, 2017
• Last Update Posted: August 28, 2017
• Sponsor: University of Roehampton
• Information provided by (Responsible Party): DR ADELE COSTABILE, University of Roehampton

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Lactobacillus plantarum ECGC 13110402; Dietary Supplement: Maltodextrin	Not Applicable

Detailed Description:

The aim of this human volunteer study was to establish tolerance, and the extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy, normal to mildly hypercholesterolaemic adults (30-65 years old).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• 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 in normal to mildly hypercholesterolaemic adults
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double Blind (Participant, Investigator,Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lactobacillus plantarum ECGC 13110402; 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; Lactobacillus plantarum ECGC 13110402
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 twice daily, before breakfast and dinner with 250mL of water.	Dietary Supplement: Maltodextrin

Outcome Measures

Primary Outcome Measures :

1. Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402 [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]
   Effects of the probiotic on TC, LDL-C, HDL-C and TAG

Secondary Outcome Measures :

1. Modulation of immune function by L. plantarum ECGC 13110402 [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]
   Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production

Other Outcome Measures:

1. Digestive symptoms [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]
   Bristol diary form Bristol diary form
2. Microbiota changes [ Time Frame: Changes from baseline to 6-12 week treatment period with the probiotic ]
   DNA profiling from faeces

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Contacts and Locations

Sponsors and Collaborators

University of Roehampton

Investigators

• Study Director: Glenn R Gibson; The University of Reading

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: DR ADELE COSTABILE, Health Sciences Research Centre, Life Science Department, University of Roehampton
• ClinicalTrials.gov Identifier: NCT03263104
• Other Study ID Numbers: UREC 15/06
• First Posted: August 28, 2017
• Last Update Posted: August 28, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No