A nutritional supplement based on a synbiotic combination of Bacillus subtilis DSM 32315 and L-alanyl-L-glutamine improves glucose metabolism in healthy prediabetic subjects – A real-life post-marketing study

Abstract

IntroductionImpaired glucose homeostasis is a significant risk factor for cardiometabolic diseases, whereas the efficacy of available standard therapies is limited, mainly because of poor adherence. This post-marketing study assessed the glucose-lowering potential of a synbiotic-based formulation.MethodsOne hundred ninety-two participants were enrolled in a digital nutrition program with continuous glucose monitoring (CGM) and received a study product comprising Bacillus subtilis DSM 32315 and L-alanyl-L-glutamine. Participants underwent a first sensor phase without supplementation, followed by a 14-day supplementation phase without sensor, and completed by a second sensor phase while continuing supplementation. Fasting glucose levels were determined before and after supplementation by CGM. In addition, the postprandial glycemic response to an oral glucose challenge, body weight, HbA1c concentrations, and BMI was analyzed. Subgroup analyses of subjects with elevated glucose and HbA1c levels vs. normoglycemic subjects were performed.ResultsSupplementation with the study product resulted in significant improvements in glucose parameters (delta values: fasting glucose –2,13% ± 8.86; iAUC0–120 –4.91% ± 78.87; HbA1c: –1.20% ± 4.72) accompanied by a significant weight reduction (−1.07 kg ± 2.30) in the study population. Subgroup analyses revealed that the improvements were mainly attributed to a prediabetic subgroup with elevated fasting glucose and HbA1c values before supplementation (delta values: fasting glucose −6.10% 4± 7.89; iAUC0–120 –6.28% ± 115.85; HbA1c −3.31% ± 4.36; weight: −1.47 kg ± 2.82).ConclusionThis study indicates that the synbiotic composition is an effective and convenient approach to counteract hyperglycemia. Further placebo-controlled studies are warranted to test its efficacy in the treatment of cardiometabolic diseases.

Tolerability of glutamine supplementation in older adults: a double-blind placebo-controlled randomized clinical trial

“…Additionally, there is a lack of investigations into the tolerability of this amino acid among the older adult population. Our hypothesis was that glutamine is safe for older adults, as previously established for younger patients ( 15 , 23 - 26 ). To test this hypothesis, we conducted a double-blind placebo-controlled randomized study comparing older adults receiving oral effervescent glutamine (EGln) or maltodextrin (placebo) for 60 days.…”

“…Additionally, there is a lack of investigations into the tolerability of this amino acid among the older adult population. Our hypothesis was that glutamine is safe for older adults, as previously established for younger patients (15,(23)(24)(25)(26).…”

Spore-Based Probiotic Bacillus subtilis: Current Applications in Humans and Future Perspectives

“…A follow-up exploratory human study used the same synbiotic supplementation [11]. A cohort of men and women consumed two capsules of synbiotic formulation (SAMANA ® Force, Evonik, Darmstadt, Germany) daily for 4 weeks.…”

“…In an aerobic environment, B. subtilis uses oxygen as an electron acceptor. However, under the oxygen-deprived conditions of the GI tract of mammals, it can utilize anaerobic metabolic pathways by expressing nitrate reductase genes, which enable the utilization of nitrate instead of oxygen as a final electron acceptor [11,12]. This anaerobic pathway allows B. subtilis to complete its entire lifecycle in the mammalian GI tract: from the germination of the spore into its vegetative state to its proliferation and subsequent sporulation [13][14][15][16].…”

Metabolic modelling reveals increased autonomy and antagonism in type 2 diabetic gut microbiota

“…Faecal samples were obtained from each participant and processed as described by Kordowski and others (20). The 16S rRNA gene sequences were acquired using Illumina paired-end shortread sequencing.…”