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

NCT ID: NCT03540108

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-04-01

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.

Detailed Description

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).

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: L. plantarum ECGC 13110402 (LPLDL®)

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.

Group Type: EXPERIMENTAL

Lactobacillus plantarum ECGC 13110402

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Please see intervention description above.

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator: Maltodextrin

Please see intervention description above.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roehampton

OTHER

Sponsor Role: lead

Responsible Party

DR ADELE COSTABILE

Reader in Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adele Costabile, PhD

Role: STUDY_DIRECTOR

University of Roehampton

Locations

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

London, UK, United Kingdom

Countries

United Kingdom

Other Identifiers

LSC 18/ 241

Identifier Type: -

Identifier Source: org_study_id