Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults—Randomized Controlled Trial

Abstract

BackgroundThe gut microbiota is interlinked with obesity, but direct evidence of effects of its modulation on body fat mass is still scarce. We investigated the possible effects of Bifidobacterium animalisssp. lactis 420 (B420) and the dietary fiber Litesse® Ultra polydextrose (LU) on body fat mass and other obesity-related parameters.Methods225 healthy volunteers (healthy, BMI 28–34.9) were randomized into four groups (1:1:1:1), using a computer-generated sequence, for 6 months of double-blind, parallel treatment: 1) Placebo, microcrystalline cellulose, 12 g/d; 2) LU, 12 g/d; 3) B420, 1010 CFU/d in microcrystalline cellulose, 12 g/d; 4) LU + B420, 12 g + 1010 CFU/d. Body composition was monitored with dual-energy X-ray absorptiometry, and the primary outcome was relative change in body fat mass, comparing treatment groups to Placebo. Other outcomes included anthropometric measurements, food intake and blood and fecal biomarkers. The study was registered in Clinicaltrials.gov (NCT01978691).FindingsThere were marked differences in the results of the Intention-To-Treat (ITT; n = 209) and Per Protocol (PP; n = 134) study populations. The PP analysis included only those participants who completed the intervention with > 80% product compliance and no antibiotic use. In addition, three participants were excluded from DXA analyses for PP due to a long delay between the end of intervention and the last DXA measurement. There were no significant differences between groups in body fat mass in the ITT population. However, LU + B420 and B420 seemed to improve weight management in the PP population. For relative change in body fat mass, LU + B420 showed a − 4.5% (− 1.4 kg, P = 0.02, N = 37) difference to the Placebo group, whereas LU (+ 0.3%, P = 1.00, N = 35) and B420 (− 3.0%, P = 0.28, N = 24) alone had no effect (overall ANOVA P = 0.095, Placebo N = 35). A post-hoc factorial analysis was significant for B420 (− 4.0%, P = 0.002 vs. Placebo). Changes in fat mass were most pronounced in the abdominal region, and were reflected by similar changes in waist circumference. B420 and LU + B420 also significantly reduced energy intake compared to Placebo. Changes in blood zonulin levels and hsCRP were associated with corresponding changes in trunk fat mass in the LU + B420 group and in the overall population. There were no differences between groups in the incidence of adverse events.DiscussionThis clinical trial demonstrates that a probiotic product with or without dietary fiber controls body fat mass. B420 and LU + B420 also reduced waist circumference and food intake, whereas LU alone had no effect on the measured outcomes.

Roux‐en‐Y gastric bypass decreases endotoxemia and inflammatory stress in association with improvements in gut permeability in obese diabetic rats

“…To some extent, these findings indicate that RYGB induced a reduction in inflammation independent of diet control. In this study we did not include a body weight‐matched control group to interpret the extent to which RYGB could reduce intestinal permeability and inflammation; however, in the PF group, partial correction of overweight by dietary limitation was seen to correct the intestinal barrier defect, consistent with previous reports …”

“…In this study we did not include a body weight-matched control group to interpret the extent to which RYGB could reduce intestinal permeability and inflammation; however, in the PF group, partial correction of overweight by dietary limitation was seen to correct the intestinal barrier defect, consistent with previous reports. 25,26 Leakage of gut microbiota-derived LPS into the blood induces metabolic endotoxemia, which triggers enhanced inflammation and oxidative stress. 27 Nevertheless, in our previous and other's studies, 4,12 RYGB was shown to induce a markedly higher relative abundance of Proteobacteria, Gammaproteobacteria, and Betaproteobacteria and increased emergence of Fusobacteria and Clostridium, which belong to the Gram-negative bacteria and have been speculated to account for 80% of LPS concentrations in the blood.…”

Gut permeability, obesity, and metabolic disorders: who is the chicken and who is the egg?

“…Alternatively, the Lac/Man test may not be sensitive enough to detect ongoing functional barrier defects (as measured by persistent high fecal zonulin concentrations) that still cause LPS trafficking. These results are also at odds with another recent report that showed that a reduction in body fat mass in obese adults by targeting the gut microbiota through prebiotic and probiotic administration rather than dietary intervention was significantly correlated with serum zonulin concentrations (10).…”

Effects of synbiotics containing Bifidobacterium animalis subsp. lactis GCL2505 and inulin on intestinal bifidobacteria: A randomized, placebo‐controlled, crossover study

“…Synbiotics, a synergistic combination of probiotics and prebiotics, are expected to have a greater effect on the health of the host than when each is used alone, and many clinical studies of synbiotics have been conducted (Asemi, Khorrami-Rad, Alizadeh, Shakeri, & Esmaillzadeh, 2014;Childs et al, 2014;Stenman et al, 2016;Waitzberg et al, 2013). However, these reports have not shown that synbiotics have a clearly stronger effect on the numbers of intestinal bifidobacteria compared with the use of probiotics or prebiotics alone.…”