A Prospective, Randomized, Double Blind, Two Arms, Parallel, Placebo Controlled, Clinical Study to Evaluate the Efficacy of OPTIMEALTH FOOD P Supplementation in Modulating Gut Microbiome in Healthy Adults

Abstract

A structured and equilibrated gut microbiome is needed for optimal health status. Factors such as antibiotic use, caesarean-section deliveries, excessive hygiene, stress, and lack of exercise have a major impact on the microbiome which further leads to microbiota shift. This shift may trigger the development of several disorders, such as obesity, metabolic syndrome, cardiovascular diseases, colorectal cancer and Inflammatory Bowel Diseases (IBD). The present study was designed to evaluate the efficacy and safety of the formulation OPTIMEALTH® FOOD P (OF PB-LBF) on gut microbiota population. OPTIMEALTH® FOOD P® is composed of more than 300 metabolites produced by a selected complex of lactic acid bacteria strains through high tech Fermentation Technology. OPTIMEALTH® FOOD P was developed by studying the microbiota of healthy centenarians who have a particular microbiota profile. A total of 59 subjects compliant with inclusion criteria were randomly assigned to one of the two groups, OPTIMEALTH® FOOD P or placebo group using a simple randomization process. Consumption of OPTIMEALTH® FOOD P by healthy men and women with self-selected diets and unchanged physical activity patterns resulted in the group of OPTIMEALTH® FOOD P in an increased of Bifidobacterium longum by 27.5%, Lactobacillus acidophilus by 24.6%, Lactobacillus plantarum by 28.6%, Roseburia intestinalis by 14.5%, Faecalibacterium prausnitzii by 23.4% and an increase of Akkermansia muciniphila by 11.11%. In conclusion, supplementation with OPTIMEALTH® FOOD P resulted in significant gut microbiota modulation. The tolerance was good among subjects. No side effects or adverse events were reported during the study. Hence OPTIMEALTH® FOOD P at 100 mg/day could be recommended as a safe solution to modulate gut microbiota and improve diseases related to microbiota dysbiosis.