Safety evaluation of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74.

The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74 by Genencor International B.V. The production strain met all requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.536 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain NZYM-WR.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Bacillus amyloliquefaciens strain NZYM-WR by Novozymes A/S. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in nine food manufacturing processes: processing of cereals and other grains for the production of baked products, cereal-based products other than baked, glucose syrups and other starch hydrolysates, distilled alcohol and brewed products; production of refined and unrefined sugar, production of plant-based analogues of milk and milk products; processing of fruits and vegetables for the production of juices and fruit and vegetable products other than juices. Since residual amounts of total organic solids (TOS) are removed during two processes, a dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 0.450 mg TOS/kg body weight per day in European populations. As the production strain qualified for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Zinc Levels and Diabetic Foot Ulcers: A Mini Review.

The aim of this nonsystematic mini review was to discuss serum levels of zinc in subjects with diabetic foot ulcers (DFUs). Most studies have reported low zinc levels in subjects with DFUs. Furthermore, there is some evidence that oral zinc supplementation may have a positive and beneficial impact on DFUs healing. Nonetheless, findings have so far not provided definitive answers. More studies are needed to clarify the role of zinc and its supplementation in this setting.

Safety evaluation of the food enzyme glucose oxidase from the genetically modified Saccharomyces cerevisiae strain LALL-GO.

The food enzyme glucose oxidase (ß-d-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Saccharomyces cerevisiae strain LALL-GO by Lallemand Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism, but not from recombinant DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.233 mg total organic solids/kg body weight per day in European populations. Since the production strain meets the requirements for the Qualified Presumption of Safety approach and no issues of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. The glucose oxidase under assessment shows sequence homology with an allergen from almond, which is listed in the Annex II of the Regulation (EU) No 1169/2011. Other than potential allergic reactions, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain LMG-S 32676.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain LMG-S 32676 by Enmex SA de CV, a Kerry Company. The food enzyme under assessment is intended to be used in six food manufacturing processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, refined and unrefined sugar production and yeast processing. Since residual amounts of total organic solids (TOS) are removed in distilled alcohol production and starch processing for glucose syrups production and other starch hydrolysates, the dietary exposure estimation was made only for the remaining four food processes. It was estimated to be up to 2.998 mg TOS/kg body weight per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Dietary and Nutritional Supplementation for Painful Diabetic Neuropathy: A Narrative Review.

Painful diabetic neuropathy (PDN) is a serious and very common complication of diabetes mellitus (DM). It negatively affects the quality of life, increases morbidity and poses a financial burden on the health care system. Currently, treatment of PDN focuses on glycaemic control, while pathogenesis-oriented therapy has not yielded satisfactory results. The need to improve therapy remains. There is accumulating evidence on the potential benefit of nutritional interventions. This narrative review aims to examine the potential benefit of dietary and nutritional supplementation for PDN management. According to the preliminary research, supplementation with vitamin E, B-complex, omega-3 fatty acids, CoQ10 or N-acetylcysteine seems to be associated with promising results in improving PDN symptoms.

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain BA.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice-based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, under the intended conditions of use.

Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain DP-Dzx96.

The food enzyme subtilisin (serine endopeptidase, EC 3.4.21.62) is produced with the non-genetically modified Bacillus paralicheniformis strain DP-Dzx96 by Genencor International B.V. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes: production of protein hydrolysates from plants and fungi, production of protein hydrolysates from meat and fish proteins, production of cooked rice, production of modified meat and fish products, and yeast processing. The production strain of the food enzyme contains known antimicrobial resistance genes. Bacitracin, a medically important antimicrobial, was detected in the food enzyme. The presence of bacitracin represents a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory and two matches with food allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to muskmelon or pomegranate, cannot be excluded, but would not exceed the risk of consuming these foods. Due to the presence of bacitracin, the Panel concluded that the food enzyme subtilisin produced with the non-genetically modified Bacillus paralicheniformis strain DP-Dzx96 cannot be considered safe.

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus licheniformis strain T74.

The food enzyme α-amylase (4-α-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus licheniformis strain T74 by Novozymes A/S. The production strain met the qualifications of the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, refined and unrefined sugar production, brewing processes, cereal-based processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and the production of dairy analogues. Since residual amounts of total organic solids (TOS) are removed during two food processes (starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production), dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 0.291 mg TOS/kg body weight per day in European populations. Since the production strain meets the requirements for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Food manufacturing processes and technical data used in the exposure assessment of food enzymes.

Food enzymes are used for technical purposes in the production of food ingredients or foods-as-consumed. In the European Union, the safety of a food enzyme is evaluated by EFSA on the basis of a technical dossier provided by an applicant. Dietary exposure is an integral part of the risk assessment of food enzymes. To develop exposure models specific to each food manufacturing process in which food enzymes are used, different input data are required which are then used in tandem with technical conversion factors. This allows the use levels of food enzyme to be related to food consumption data collected in dietary surveys. For each food manufacturing process, EFSA identified a list of food groups (FoodEx1 classification system) and collated technical conversion factors. To ensure a correct and uniform application of these input data in the assessment of food enzyme dossiers, stakeholders were consulted via open calls-for-data. In addition to publishing and updating the identified input parameters on an annual basis, single-process-specific calculators of the Food Enzyme Intake Models (FEIMs) have been developed. These calculators have been deposited at https://zenodo.org/ since 2018 for open access. By 2023, EFSA had compiled the input data for a total of 40 food manufacturing processes in which food enzymes are employed. In this document, the food manufacturing processes are structured, food groups classified initially in the FoodEx1 system are translated into the FoodEx2 system, and technical factors are adjusted to reflect the more detailed and standardised FoodEx2 nomenclature. The development of an integrated FEIM-web tool using this collection of input data is carried out for a possible release in 2024. This tool will be able to estimate the exposure to the food enzyme-total organic solids (TOS) when employed in multiple food manufacturing processes.

Safety evaluation of the food enzyme endo-1,4-ß-xylanase from the non-genetically modified Aspergillus tubingensis strain LYX.

The food enzyme endo-1,4-ß-xylanase (4-ß-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the non-genetically modified microorganism Aspergillus tubingensis strain LYX by DSM Food Specialties B.V. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in baking processes and cereal-based processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.106 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 227 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2,142. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Magnesium and Diabetic Foot Ulcers: A Mini Review.

There is accumulating evidence that magnesium, an important mineral having a pivotal role in many physiological functions, may be important in development and healing of diabetic foot ulcers (DFUs). In this non-systematic mini review, we discuss the role of magnesium in DFUs, as well as the effects of magnesium administration in DFUs. Reduced Mg levels appear to be associated with DFUs. Moreover, Mg administration may be beneficial for the outcome of DFUs. Further investigation is imperative in order to shed more light on these findings.

The Role of Nutrients and Diet Characteristics in the Management of Diabetic Foot Ulcers: A Systematic Review.

Diabetic foot ulcers (DFUs) are common complications of diabetes mellitus that affect patients' quality of life and pose a burden on the healthcare system. Although malnutrition and specific nutritional deficiencies can seriously impact wound healing in patients with chronic nonhealing wounds, the role of nutrition in the prevention and management of DFUs is still not clear. This review discusses the significance of frequent diet assessment and nutritional education of patients with DFUs with individualized correction of deficiencies and emphasis on adequate protein intake along with correction of vitamins D, C, E, and selenium status. Future research should clarify the impact of nutritional interventions, potentially involving the use of probiotics, zinc, and omega-3 fatty acids, and successfully translating the findings into practical guidelines for use in everyday clinical practice.

Association between daily number of eating occasions with fasting glucose and insulin sensitivity in adults from families at high risk for type 2 diabetes in Europe: the Feel4Diabetes Study.

OBJECTIVE: The aim of this study was to examine the association between the number of times one eats daily (termed eating occasions [EO]) with indices of glycemic control and insulin resistance (IR) in a large sample of adults from families at high risk for type 2 diabetes mellitus (T2DM) from six European countries. The study also considered sex and socioeconomic status (SES). METHODS: Standardized questionnaires and procedures were used to assess sociodemographic characteristics, dietary intake, sedentary behavior, and anthropometric and biochemical indices. Univariate analysis of variance was used to investigate associations of daily EOs with fasting glucose (FG), fasting insulin (FI), and IR. RESULTS: In 1552 adults (41.6 ± 7.2 y), three to four daily EOs rather than less than three were inversely associated with FG (ß = -2.598; 95% confidence interval [CI], -4.521 to -0.675), independent of age, body mass index (BMI), dietary quality, and sedentary time. In women, three to four EOs per day were also associated with FG (ß = -3.071; 95% CI to -5.573 to -0.570) independently of the mentioned confounders. In high SES participants, having more than four EOs per day had an inverse association with FI (ß = -1.348; 95% CI to -2.583 to -0.114). No such associations were observed in men or in low SES participants. CONCLUSION: In adults at high risk for T2DM, and especially in women, having three to four daily EOs was inversely associated with FG, whereas in high SES participants, more than four EOs was associated with FI. Future studies should further elucidate the underlying mechanisms and offer insight into the optimum number of daily EOs for the prevention of T2DM especially in men and in adults with low SES where the number of daily EOs was not found to be significantly related to glycemic indices.

Socio-Demographic Characteristics and Body Weight Perceptions of Study Participants Benefitting Most from the Feel4Diabetes Program Based on Their Anthropometric and Glycaemic Profile Changes.

The Feel4Diabetes program was comprised of a community-based screening and a two-year intervention phase aiming to prevent type 2 diabetes (T2D) in families at risk for diabetes across Europe. The current work aimed to identify the socio-demographic characteristics and body weight perceptions of participants who benefitted the most, achieving at least a 5% reduction in body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels), over two-year period. Following a two-stage screening procedure, 2294 high-risk parents were randomly allocated to standard care or more intensive intervention. The participants who benefitted most were living in Southern (OR 2.39-3.67, p < 0.001) and Eastern Europe (OR 1.55-2.47, p < 0.05), received more intensive intervention (OR 1.53-1.90, p = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51, p < 0.05). Furthermore, individuals with tertiary education (OR 2.06, p < 0.001), who were unemployed (OR 1.62-1.68, p < 0.05) and perceived their body weight to be higher than normal (OR 1.58-3.00, p < 0.05) were more likely to benefit from the program. Lastly, males were more likely to show improvements in their glycaemic profiles compared to females (OR 1.40, p = 0.024). These findings point out the regions in Europe and the sociodemographic profile of individuals that benefitted the most in the current study, highlighting the need to prioritise regions in greater need for such interventions and also tailor future interventions to the characteristics and perceptions of the target populations.

Adherence to the Mediterranean Diet and Healthy Aging: A Narrative Review over the Last Decade.

Objective: Even though modern medicine has significantly contributed to the extension of human lifespan, it has failed to delay the upsurge of chronic diseases. Health benefits of the Mediterranean diet are well established. Thus, adherence to this diet pattern may be the key to healthy aging. Ôhe aim of this review is to investigate the potential benefits of the Mediterranean diet on healthy aging. Methods: A literature search of three databases (ScienceDirect, MEDLINE and The Cochrane Library) was conducted in order to trace all relevant studies published between January 1st 2010 and June 6th 2020 that focused on the impact of adherence to the Mediterranean diet on the physical and mental well-being of individuals aged 60 or older. Results:Twenty-two studies fulfilled the selection criteria and were classified into six groups, according to the main outcome of each study: mental health (eight studies), frailty (6), cardiovascular risk factors (3), plasma levels of uric acid (1), length of hospital stay (1), and aging mechanisms (3). Based on these studies, the protective role of Mediterranean diet on depression, cardiovascular and frailty risk was established. Moreover, adherence to the Mediterranean diet resulted in reduced plasma uric acid levels as well as decreased length of hospital stay and mortality risk among patients who were urgently admitted for any cause in a tertiary hospital. In contrast, results on the effect of Mediterranean diet on cognition were controversial, as studies presented positive or neutral correlations. Conclusions: This review provides evidence on the association between adherence to the Mediterranean diet and healthy aging and highlights the importance of conducting more studies among seniors in order to provide further insight into this matter.