Probio cholesterol lowering Study
Research type
Research Study
Full title
An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum LP-LDL® in hypercholesterolaemic adults.
IRAS ID
259363
Contact name
Adele Costabile
Contact email
Sponsor organisation
R&D Director OptiBiotix Health PLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Coronary heart disease (CHD) is the world’s leading cause of death and a major source of disability. High total cholesterol levels have been established as a key risk factor for this disease. This study will investigate the cholesterol-lowering effects of a probiotic strain LP-LDL® developed by the Life Sciences Company Optibiotix Health PLC for its ability not only to degrade harmful excess cholesterol but also to interfere with its formation.
Probiotics are ‘live microbial food supplements that offer a benefit to health’, safe for human consumption. Lactobacilli are common components of the human intestine and used by the food industry as probiotics for general health benefits. Modifiable risk factors for CHD, diet and exercise, prove challenging for modern lifestyles and are difficult habits to change and maintain in the long-term. Drug therapies, e.g. statins, are costly, produce unwanted side effects and are ineffective in 10-20% of cases. Consequently, this probiotic might constitute a cost-effective well- tolerated natural dietary therapy which is easier for individuals to adhere to.
A previous double-blinded randomised controlled human study with LP-LDL® was performed by OptiBiotix in 49 subjects with normal to mildly high cholesterol (Costabile et al., 2017). LP-LDL® showed to: be safe and well- tolerated; lower total cholesterol by up to 36.7%; lower ‘bad’ cholesterol by up to 13.9%, increase ‘good’ cholesterol by up to 6.5%; and lower systolic blood pressure by 5.1%. This will be a 12-week follow-up human intervention study in adults (30-65y) with high cholesterol (TC > 6mM).
Studies have found that vitamin D deficiency has been associated with CHD. Vitamin D is necessary for cholesterol metabolism but, inversely, a disturbed cholesterol metabolism affects the body’s ability to use vitamin D. Furthermore, there is evidence that vitamin D absorption could also be improved by the probiotic of interest which the study will examine also.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0724
Date of REC Opinion
12 Aug 2019
REC opinion
Further Information Favourable Opinion