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This opinion deals with the re‐evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5‐14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short‐chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment‐related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose‐N as a food additive (E 1200) is no longer marketed in the EU.

ABSTRACT Short chain fatty acids (SCFAs) derived from the human gut microbiota, and in particular propionate, may beneficially influence metabolic processes such as appetite regulation. Development of prebiotics that induce high propionate levels during fermentation is desirable. A total of 11 candidate prebiotics were screened to investigate their fermentation characteristics, with a focus on propionate production in mixed anaerobic batch culture of faecal bacteria. Further to this, a continuous 3-stage colonic fermentation model (simulating the human colon) was used to evaluate changes in microbial ecology, lactate and SCFA production of three 50:50 blends, comprising both slow and rapidly fermented prebiotics. In mixed batch culture: xylo-oligosaccharide, polydextrose and α-gluco-oligosaccharide were associated with the greatest increase in propionate. Polydextrose, α-gluco-oligosaccharide, β-1,4 glucan and oat fibre induced the greatest reductions in the acetate to propionate ratio. The most bifidogenic prebiotics were the oligosaccharides. Fermentation of a 50:50 blend of inulin and arabinoxylan, through the continuous 3-stage colonic fermentation model, induced a substantial and sustained release of propionate. The sustained release of propionate through the colon, if replicable in vivo, could potentially influence blood glucose, blood lipids and appetite regulation, however, dietary intervention studies are needed. Bifidogenic effects were also observed for the inulin and arabinoxylan blend and an increase synthesis of butyrate and lactate, thus indicating wider prebiotic potential. Screening candidate prebiotics to identify high propionate producers and go on to develop prebiotic blends that induce sustained propionate production in the gut to improve the metabolic health of the host.

•Prebiotic intake improved and changed immunologic indicators and intestinal microbiota structure in colorectal patients in the perioperative period.•Prebiotics increased the abundance of some commensal microbiota containing opportunistic pathogens in CRC patients.•Surgical stress decreased the abundance of most intestinal microbiota in the intestinal tract but increased the abundance of some opportunistic pathogens and commensals microbiota.•Bacteroides is a relevant bacteria for further research on the mechanism with prebiotics. The aim of the present study was to investigate the effects of prebiotics (containing fructooligosaccharides, xylooligosaccharides, polydextrose, and resistant dextrin) intake on immune function and intestinal microbiota structure in perioperative patients with colorectal cancer (CRC). A randomized, double-blind, no-treatment parallel control clinical trial involving 140 perioperative patients (90 men and 50 women, aged 40–75 y) with CRC was performed. Patients were randomly divided into two groups: an intervention group (prebiotic group, n = 70) that received prebiotic supplementation of 30 g/d for 7 d, and a control group (non-prebiotic group, n = 70) that received no prebiotic supplementation. The nutritional and immunologic indices were evaluated for both groups before and after operation and analyzed against baseline values. Moreover, fecal samples were collected from 40 patients randomly chosen from the two groups to study intestinal microbiota, which was analyzed by sequencing the V3–V4 region of 16S ribosomal DNA using the Illumina (San Diego, CA) MiSeq (PE 2 × 300 bp) platform. Oral intake of prebiotics produced significant effects on immunologic indices in both the preoperative and postoperative periods, but the patterns of effects were different. In the preoperative period, prebiotics increased serum levels of immunoglobulin G (IgG; P = 0.02), IgM (P = 0.00), and transferrin (P = 0.027; all P < 0.05). In the postoperative period, enhanced levels of IgG (P = 0.003), IgA (P = 0.007), suppressor/cytotoxic T cells (CD3+CD8+; P = 0.043), and total B lymphocytes (CD19+; P = 0.012) were identified in the prebiotic group (all P < 0.05). The differences in the intestinal microbiota at the phylum level were not statistically significant between the intervention and control groups (P > 0.05). At the genus level, prebiotics increased the abundance of Bifidobacterium (P = 0.017) and Enterococcus (P = 0.02; both P < 0.05) but decreased the abundance of Bacteroides (P = 0.04) in the preoperative period (all P < 0.05). In the postoperative period, the abundance of Bacteroides (P = 0.04) was decreased, but the abundance of Enterococcus (P = 0.00), Bacillus (P = 0.01), Lactococcus (P = 0.00), and Streptococcus (P = 0.037) increased in the non-prebiotic group (all P < 0.05); however, no significant change was identified in the abundance of Enterococcus (P = 0.56), Lactococcus (P = 0.07), and Streptococcus (P = 0.56) as a result of prebiotic intervention in this period (all P > 0.05). The abundance of Escherichia-Shigella was increased after prebiotic intake in the postoperative period (P = 0.014, P < 0.05). There was a notable trend of decline in the abundance of intestinal microbiota from preoperative to postoperative in the non-prebiotic group. Prebiotic intake is recommended to improve serum immunologic indicators in patients with CRC 7 d before operation. Prebiotics improved the abundance of four commensal microbiota containing opportunistic pathogens in patients with CRC. Surgical stress decreased the abundance of most intestinal microbiota in the intestinal tract but increased the abundance of some opportunistic pathogens and commensal microbiota. Bacteroides is a relevant bacterial species for further research on the mechanism of prebiotics.

RationaleThe impact of the microbiota on the gut-brain axis is increasingly appreciated. A growing body of literature demonstrates that use of dietary fibre and prebiotics can manipulate the microbiota and affect host health. However, the influence on cognition and acute stress response is less well understood.ObjectivesThe objective of this study was to investigate the efficacy of a dietary fibre, polydextrose (PDX), in improving cognitive performance and acute stress responses through manipulation of the gut microbiota in a healthy population.MethodsIn this double-blind, randomised, placebo-controlled, crossover design study, 18 healthy female participants received 12.5 g Litesse®Ultra (> 90% PDX polymer) or maltodextrin for 4 weeks. Cognitive performance, mood, acute stress responses, microbiota composition, and inflammatory markers were assessed pre- and post-intervention.ResultsPDX improved cognitive flexibility as evidenced by the decrease in the number of errors made in the Intra-Extra Dimensional Set Shift (IED) task. A better performance in sustained attention was observed through higher number of correct responses and rejections in the Rapid Visual Information Processing (RVP) task. Although there was no change in microbial diversity, abundance of Ruminiclostridium 5 significantly increased after PDX supplementation compared with placebo. PDX supplementation attenuated the increase of adhesion receptor CD62L on classical monocytes observed in the placebo group.ConclusionsSupplementation with the PDX resulted in a modest improvement in cognitive performance. The results indicate that PDX could benefit gut-to-brain communication and modulate behavioural responses.

The probiotic viability, physicochemical, mechanical, barrier, and microstructure properties of synbiotic edible films (SEFs) based on duck feet gelatin (DFG) were evaluated. Four synbiotic systems were obtained by mixing four types of prebiotics, namely, dextrin, polydextrose, gum Arabic, and sago starch, with DFG to immobilize of probiotic (Lactobacillus casei ATCC). The ability of DFG to create a suitable matrix to increase probiotic viability was compared with those of other commercial gelatins in a preliminary evaluation. The DFG showed proper probiotic viability compared with other gelatins. The addition of prebiotics reduced the transparency of SEFs and increased color differentiation, uniformity, and complete coverage of probiotic cells. The estimated shelf-life of surviving bacteria in the SEFs stored at 4 and 25 °C showed that gum arabic showed the best performance and enhanced the viability of L. casei by 42% and 45%, respectively. Dextrin, polydextrose, and sago starch enhanced the viability of L. casei at 4 and 25 °C by 26% and 35%, 26% and 5%, and 20% and 5%, respectively. The prebiotics improved the physicochemical, mechanical, and barrier properties of all SEFs, except polydextrose film. The viability of L. casei can be increased with the proper selection of gelatin and prebiotics.

Two infant formulas with unique combinations of 1,3-dioleoyl-2-palmitoyl-sn-glycerol sn2 palmitate, galactooligosaccharide, polydextrose, fructooligosaccharide, β-carotene, lutein, α-lactalbumin, osteopontin, and lactoferrin were evaluated for non-inferiority compared to a commercially available formula. In a randomized, controlled, parallel-arm, double-blind, multicenter, non-inferiority study, eligible infants were enrolled to receive an experimental (BBN-001 [Part 1; N = 129], BBN-102 [Part 2; N = 117]) formula or commercial formula (Brand; N = 143) for 120 days (Clinical Trials.gov NCT03331276). Infants were considered eligible if they were healthy, term (≥ 37 and ≤ 42 weeks of gestation), singleton newborns, with a birth weight of at least 2,500 g, and no more than 14 postnatal days-of-age. Anthropometric growth, formula intake, gastrointestinal tolerance, and adverse events were measured throughout the study, and fecal soap fatty acids were measured at the end. The primary endpoint was weight gain at the end of the trial, with treatment groups to be considered non-inferior if their weight gain was > -3 g/d compared to the control group. Both experimental formulas were non-inferior to the Brand formula according to anthropometric outcomes. Formula intake, total adverse events, and stool frequency and consistency were similar to Brand formulas. Some measures of gassiness and fussiness improved in the experimental formulas (P < 0.05). Fecal calcium increased and fecal palmitic acid soaps decreased in both experimental formulas (all P ≤ 0.045), and total soap fatty acids were decreased in the BBN-102 group compared to the Brand group (P = 0.020). The experimental formulas were well tolerated and deemed non-inferior to those of a Brand formula. The experimental formulas improved some measures of gastrointestinal tolerance compared to standard commercially available infant formulas. ClinicalTrials.gov NCT03331276.

Background: Contrast-enhanced magnetic resonance imaging (MRI) is a powerful diagnostic tool for many diseases. In many situations, the contrasts are repeatedly administrated in order to monitor and assess the disease progression. Objective: To investigate and compare the biological effects of [gamma]-[Fe.sub.2][O.sub.3] nanoparticle (NP) and gadolinium dimeglumine (Gd-DTPA) with high and multiple doses on the kidney of healthy mice. Methods: Polydextrose sorbitol carboxymethyl ether coated [gamma]-[Fe.sub.2][O.sub.3] NP with hydrodynamic size of 68.2 nm and clinically applied Gd-DTPA were employed on healthy mice with the repeatedly intravenous administration of high doses. The cell viability of human umbilical vein endothelial cells (HUVEC) in high doses of these two contrast agents were measured using the xCELLigence Real-Time Cell Analysis (RTCA) S16 Instrument. The biological effects of [gamma]-[Fe.sub.2][O.sub.3] NP and Gd-DTPA on the kidney were obtained using a biochemical automatic analyzer and multiple proinflammatory factor kit on the serum. Histopathological and immunohistochemistry analysis were taken on kidney tissues. Results: It showed that the proinflammatory responses elicited by the [gamma]-[Fe.sub.2][O.sub.3] NPs were weaker than that by Gd-DTPA, evidenced by the relatively much lower level of IL-1p, IL-6, IL-18, TNF-[alpha], C-reactive protein (CRP) and Ferritin. At the same time, the [gamma]-[Fe.sub.2][O.sub.3] NPs did not have the biochemical index elevated, while the Gd-DTPA did. Conclusion: The [gamma]-[Fe.sub.2][O.sub.3] NPs induced weaker proinflammatory effects in reference to the Gd-DTPA, indicating better renal safety. Therefore, it is suggested that [gamma]-[Fe.sub.2][O.sub.3] NPs should be safer and optional choice when repeated contrast-enhanced MRI is necessary. Keywords: iron oxide nanoparticles, proinflammatory, cytokines, renal function

Pediococcus pentosaceus was cultivated in MRS medium supplemented or not with polydextrose under different conditions in order to evaluate its effect on cell growth, lactic acid and bacteriocin-like inhibitory substance (BLIS) production. Independent variables were pH (4.0, 5.0, 6.0), rotational speed (50, 100, 150 rpm), polydextrose concentration (0.5, 1.0, 1.5%) and temperature (25, 30, 35 °C), while cell concentration and productivity after 24 h, maximum specific growth rate, specific rate of substrate (glucose) consumption, volumetric and specific lactic acid productivities, yields of biomass and lactic acid on consumed substrate were the dependent. The maximum cell concentration (10.24 ± 0.16 g[sub.X] L[sup.−1] ) and productivity (0.42 ± 0.01 g[sub.X] L[sup.−1] h[sup.−1] ) were achieved at pH 6.0, 35 °C, 150 rpm using 1.5% polydextrose, while the maximum specific growth rate (0.99 ± 0.01 h[sup.−1] ) and yield of biomass (2.96 ± 0.34 g[sub.X] g[sub.S] [sup.−1] ) were achieved at the same pH and polydextrose concentration, but at 25 °C and 50 rpm. The specific substrate consumption rate (0.09 ± 0.02 g[sub.S] g[sub.X] [sup.−1] h[sup.−1] ) and the volumetric lactic acid productivity (0.44 ± 0.02 g[sub.P] L[sup.−1] h[sup.−1] ) were maximized at pH 6.0, 35 °C, 50 rpm and 0.5% polydextrose. BLIS produced in this last run displayed the highest antibacterial activity against Escherichia coli, while the same activity was displayed against Enterococcus faecium using 1.5% polydextrose. These results appear to be quite promising in view of possible production of this BLIS as an antibacterial agent in the food industry.

The soluble dietary fiber polydextrose (PDX) is a randomly linked glucose oligomer containing small amounts of sorbitol and citric acid and is widely used in the food industry. However, whether PDX can prevent and treat obesity in high-fat diet (HFD)-fed mice has not been directly investigated, and further studies are needed to better understand the complex interactions among PDX, adipose tissue inflammation and the gut microbiota. In the present study, PDX reduced body weight, fasting blood glucose (FBG), adipose tissue accumulation, adipocyte hypertrophy, serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels in HFD-fed mice. Moreover, PDX alleviated serum lipopolysaccharide (LPS) levels and macrophage infiltration in epididymal adipose tissue and resulted in macrophage polarization toward the M2 phenotype. Gut microbiota analysis revealed that PDX promoted the growth of beneficial microbes such as Bacteroides , Parabacteroides , Alloprevotella , Muribaculum , Akkermansia , Ruminococcaceae_UCG-014 and UBA1819 in obese mice, which were negatively correlated with subcutaneous fat, epididymal fat, body weight, FBG, serum TC, HDL-C, LDL-C and LPS levels. Our results indicates that PDX can prevent and treat obesity in HFD-fed mice, specifically in alleviating glucolipid metabolism disorders and adipose tissue inflammation, which may be mediated by modulating the structure of the gut microbiota. Therefore, PDX may become a promising nondrug therapy for obesity.

The broad spectrum of antiviral activity and relatively low toxicity of arbidol hydrochloride have made it an interesting subject of research. Additionally, there is no information available regarding its formulation with various excipients. Another drawback is its hydrophobic nature, which contributes to lower bioavailability in specific drug forms. Therefore, it is necessary to test its mixtures with excipients to identify those that can enhance its solubility in water. For this reason, tests of compatibility/incompatibility of mixtures of arbidol hydrochloride with starchy excipients such as dextrin, polydextrose, and hydroxypropyl starch were carried out using differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), thermogravimetry coupled with Fourier transform infrared spectroscopy (TGA-FTIR), and powder X-ray diffraction (PXRD). Additionally, phase diagrams were developed for arbidol hydrochloride mixtures with starchy polymers, which enabled prediction of the solubility of this active pharmaceutical ingredient (API) in polymers and the mutual miscibility of the ingredients. The study concluded that arbidol hydrochloride may be compatible with dextrin.