Effect of a Synbiotic on Body Fat Mass, Weight Management, Traits of Metabolic Syndrome and Gut Permeability in Individuals With Abdominal Overweight: a Randomised, Controlled, Double-blind Clinical Study

The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. Some probiotic species/strains, however, seem to be more efficacious (Koutnikova et al., 2019). The lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. Therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity.

The combination of these Lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut (Cherbut et al., 2003; Calame et al., 2008) and, hence, are supposed to promote their propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial (Cherbut et al., 2003; Calame et al., 2008).

Acacia gum, however, seems to have own effects on traits of the metabolic syndrome. Even though the effects still need to be confirmed in more DB-RCTs, one may suggest a separate effect, e.g. by reduction of the SGLT1in the intestine (Nasir et al., 2010).

This DB-RCT aims at providing first evidence for an effect of this symbiotic on traits of the metabolic syndrome. The target parameters were selected for allowing a health claim according to the Health Claim Directive of the EU (REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on Nutrition and Health Claims Made on Foods) and/or the REGULATION (EU) No 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 for Food for Special Medical Purposes after having confirmative evidence.

The following health claim options are feasible according to the EFSA Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations (EFSA Journal 2012;10(3):2604) and to the EFSA Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health (EFSA Journal 2011;9(12):2474):