Abstract
Background: Recent research has highlighted the potential of postbiotics for addressing obesity and associated metabolic disorders. In this randomized, double-blind clinical trial, the efficacy of a postbiotic product in managing overweight and associated parameters was assessed. Methods: Sixty individuals were randomized into two groups: one group (n = 30) received the Postbiotic (heat-killed L. fermentum strain K8-Lb1) and the other (n = 30) a Placebo control. Body weight, waist circumference, body composition, vital signs, blood biomarkers and questionnaires for quality of life, eating behavior, eating control and gastrointestinal symptoms were assessed. Results: After a 12-week intervention, body fat mass (primary parameter) was significantly (p = 0.016) reduced in the Postbiotic group (98.15 ± 3.32% of baseline) compared to the Placebo group (100.41 ± 3.39%). In line with this, body weight (p = 0.047) and waist circumference (p = 0.034) were significantly reduced and visceral fat tended to be reduced (p = 0.053). Accordingly, the Postbiotic group tended (p = 0.066) to feel more in control of their body weight. Despite weight loss, muscle mass tended (p = 0.062) to increase. ALT, AST and GGT tended to be reduced, which may indicate an improvement in liver steatosis. Estimated average glucose (eAG) differed significantly between the groups in individuals with normal fasting glucose levels. The ability to concentrate significantly (p = 0.014) improved. Conclusions: Under an ad libitum diet, the postbiotic L. fermentum strain K8-Lb1 reduced body fat mass, body weight, and waist circumference, improved the ability to concentrate, and showed a trend towards an increase in muscle mass. The results of this pilot trial need confirmation by a pivotal trial.