The Probiotic Strain H. alvei HA4597® Improves Weight Loss in Overweight Subjects under Moderate Hypocaloric Diet: A Proof-of-Concept, Multicenter Randomized, Double-Blind Placebo-Controlled Study

Abstract

Background: Increasing evidence supports the role of the gut microbiota in the control of body weight and feeding behavior. Moreover, recent studies have reported that the probiotic strain Hafnia alvei HA4597® (HA), which produces the satietogenic peptide ClpB mimicking the effect of alpha-MSH, reduced weight gain and adiposity in rodent models of obesity. Methods: To investigate the clinical efficacy of HA, 236 overweight subjects were included, after written informed consent, in a 12-week prospective, double-blind, randomized study. All subjects received standardized counselling for a −20% hypocaloric diet and were asked to maintain their usual physical activity. Subjects of the HA group received two capsules per day providing 100 billion bacteria per day and subjects in the Placebo (P) group received two placebo capsules. The primary endpoint was the percentage of subjects achieving a weight loss of at least 3% after 12 weeks. Intention-to-treat statistical analysis was performed using exact-Fischer, Mann-Whitney and paired-Wilcoxon tests as appropriate. Results: In the HA group, significantly more subjects (+33%) met the primary endpoint than in the P group (54.9 vs. 41.4%, p = 0.048). In the HA group, an increased feeling of fullness (p = 0.009) and a greater loss of hip circumference (p < 0.001) at 12 weeks were also observed. Fasting glycemia at 12 weeks was significantly lower (p < 0.05) in the HA compared to P group. Clinical and biological tolerance was good in both groups. Conclusions: A 12-week treatment with the probiotic strain H. alvei HA4597® significantly improves weight loss, feeling of fullness and reduction of hip circumference in overweight subjects following moderate hypocaloric diet. These data support the use of H. alvei HA4597® in the global management of excess weight.

Mechanisms of Glucose Absorption in the Small Intestine in Health and Metabolic Diseases and Their Role in Appetite Regulation

“…This suggests that the treatment of hyperglycemia based on SGLT1-mediated inhibition of small intestinal glucose absorption should be combined with other therapeutic strategies selectively targeting appetite control. Recent results of a clinical trial using Hafnia alvei in overweight subjects [ 103 ], suggest that development of new probiotics influencing both glycemia and appetite may represent a promising supplementary therapy for the pharmacological treatment of metabolic diseases.…”

“…Moreover, Hafnia alvei probiotic was recently shown to reduce food intake and glycemia in obese mice and overweight humans, potentially involving melanocortin-like effects of a bacterial protein caseinolytic protease B [ 102 , 103 ]. Effect of Hafnia alvei on glucose absorption has not yet been studied.…”

Microbiome First Medicine in Health and Safety

“…Table 4 illustrates examples from human clinical trials [ 131 , 148 , 149 , 150 , 151 , 152 , 153 , 154 , 155 , 156 , 157 , 158 , 159 , 160 , 161 , 162 , 163 , 164 , 165 , 166 , 167 , 168 , 169 , 170 , 171 , 172 , 173 , 174 , 175 , 176 , 177 , 178 , 179 , 180 , 181 , 182 , 183 ]. Not surprisingly, the best outcomes occur when there is a clear understanding of the specific microbes, genes, metabolic changes, and installation conditions that are needed to support microbiome-driven physiological benefits.…”

Whole Genome Sequence Analysis of a Novel Apilactobacillus Species from Giant Honeybee (Apis dorsata) Gut Reveals Occurrence of Genetic Elements Coding Prebiotic and Probiotic Traits

“…The CLP chaperone protein is a mimetic of the anorexigenic α-melanocyte stimulating hormone (α-MSH). Several recent studies on mice model have shown that the prevalence of this gene in enterobacteria resulted in reduced adiposity and weight gain in obesity rodent models [ 49 , 50 , 51 ]. This fact is further strengthened by the finding that low enterobacterial Clp B gene abundance was observed in the microbiota of obese humans [ 52 ].…”