In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors for CVD and diabetes in overweight type 2 diabetics is investigated.
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. 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Consumption of 6 g powder consisting of the strains Lactobacillus fermentum K7-Lb1, L. fermentum K8-Lb1, L. fermentum K11-Lb3, acacia gum (gum arabic), maltodextrin, sucralose and flavour twice a day resolved in water
Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water
Slimbiotics GmbH
Vienna, Austria
Clinical Research Center Kiel
Kiel, Germany
BFM
Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group)
Time frame: 12 weeks
HbA1c
Glycated Hemoglobin
Time frame: 12 weeks
HOMA-IR
HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose \[mmol/L\] x insulin \[µU/ml\]/22,5) as parameter for insulin resistance
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.