Investigation of the potential for a simplified exposure tool in medical nutrition (SETIM) to minimise exposures to sweeteners in young patients aged 1–3 years with PKU and CMPA

Children with phenylketonuria (PKU) and severe cow’s milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) in addition to having restricted intake of normal foods. These vulnerable patients are exposed to artificial sweeteners from the consumption of a combination of both free and prescribed foods. Young patients with PKU and CMPA aged from 1 to 3 years have a higher risk of exceeding the acceptable daily intake (ADI) for sweeteners than age-matched healthy children. A probabilistic modelling approach has been adapted successfully to assess the exposure of young patients with PKU and CMPA to low-calorie sweeteners. To assist professionals in the screening and formulation of foods containing food additives for such patients, a simplified exposure method/tool has been developed. The tool is intended to ensure that total dietary exposure can be considered. The simplified tool is not intended to replace the probabilistic model but may be used as a screening tool to determine if further investigation on exposure is warranted. The aim of this study was to develop and validate this simplified exposure tool to support those currently used by healthcare professionals (HCPs) using data available from the probabilistic modelling of exposure in young children with PKU and CMPA. The probabilistic model does not allow for swift screening of exposure scenarios nor is the present EFSA Food Additive Intake Assessment Model (FAIM) fully suitable for application to medical foods. The simplified exposure tool in medical nutrition (SETIM) reported here is both reliable and consistent and provides additive usage levels which minimise regular exposure above the ADI in patients. In addition to the usefulness of SETIM for the medical nutrition industry, the tool has the potential to enhance the practice of evidence-based medical nutrition by official risk assessment bodies, registration authorities and healthcare professionals.     

Predictive modelling of the exposure to steviol glycosides in Irish patients aged 1-3 years with phenylketonuria and cow’s milk protein allergy

Children with Phenylketonuria (PKU) and severe cow’s milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) as well as restricted amounts of normal foods. These patients are exposed to artificial sweeteners from the consumption of a combination of free and prescribed foods. Young patients with PKU and CMPA have a higher risk of exceeding acceptable daily intakes (ADI) for additives than age-matched healthy children. A predictive modelling approach has been adapted successfully to assess the additive exposure of young patients with PKU and CMPA to artificial sweeteners. Steviol glycosides (E960) are at various stages of regulatory approval for the various food categories in the EU but are not as yet permitted for use in products intended for young children. The aim of this study was to predict potential steviol glycoside exposure in young children with PKU and CMPA considering the potential for future provisions for the use of this sweetener. The recent introduction of steviol glycosides means that no exposure data are available for children with CMPA and PKU. Food consumption data were derived from the food consumption survey data of healthy young children in Ireland from the National Preschool and Nutrition Survey (NPNS, 2010–11). Specially formulated amino acid-based FSMPs are used to replace whole or milk protein foods and were included in the exposure model to replace restricted foods. The recommendations to ensure adequate protein intake in these patients were used to determine FSMP intake. Exposure assessment results indicated that the maximum permitted level (MPL) for FSMPs would warrant careful consideration to avoid exposures above the ADI. These data can be used to inform recommendations for the medical nutrition industry.     

Residue analyses and exposure assessment of the Irish population to nitrofuran metabolites from different food commodities in 2009–2010

An exposure assessment to nitrofuran residues was performed for three human populations (adults, teenagers and children), based on residue analyses of foods of animal origin (liver, honey, eggs and aquaculture) covering the 2-year period 2009–2010. The occurrence of nitrofuran metabolites in food on the Irish market was determined for the selected period using the data from Ireland’s National Food Residue Database (NFRD) and from results obtained from the analysis of retail samples (aquaculture and honey). Laboratory analyses of residues were performed by methods validated in accordance with Commission Decision 2002/657/EC regarding performance of the analytical method and interpretation of results. Semicarbazide (SEM) was the contaminant most frequently identified and its content ranged from 0.09 to 1.27 μg kg^?1. SEM is currently used as a marker of nitrofuran abuse, but it may also occur from other sources. The presence of nitrofuran metabolite 3-amino-2-oxazolidinone (AOZ) was detected in two aquaculture samples (prawns) at 1.63 and 1.14 μg kg^?1, but such a low number of positive cases did not present sufficient data for a full AOZ exposure assessment. Therefore, the evaluation of exposure was focused on SEM-containing food groups only. Exposure assessments were completed using a probabilistic approach that generated 10 iterations. The results of both the upper- and lower-bound exposure assessments demonstrate that SEM exposure for Irish adults, teenagers and children from selected food commodities are well below EFSA-estimated safe levels.     

Efficacy of artificial tears containing trehalose and hyaluronic acid for dry eye disease in women aged 42–54 versus ≥ 55 years

Background and objectivesDry eye disease (DED) is common in postmenopausal women. This study evaluated efficacy of a 3-month daily treatment with artificial tears containing trehalose and hyaluronic acid (HA) in women aged 42–54 years (mixed-hormonal status) versus ≥ 55 years (postmenopausal) and with moderate and severe DED.MethodsThis was a post-hoc analysis of three clinical trials assessing the efficacy of artificial tears containing trehalose (3%) and HA (0.15%) in women with an Ocular Surface Disease Index (OSDI) ≥ 18. Patients instilled one drop of the artificial tears in each eye 3 to 6 times daily and were evaluated at baseline and after 84 ± 7 days for DED symptom severity (OSDI), hyperemia (McMonnies scale), tear break-up time (TBUT), corneal and conjunctival staining (Oxford and Van Bjisterveld scales), tear production (Schirmer I test), and ocular symptoms.ResultsA total of 273 women were evaluated, 61 of age 42–54 years; 212 of ≥ 55 years. DED symptoms, as measured by the OSDI, decreased significantly with the treatment in both age groups (p < 0.0001). Conjunctival hyperemia decreased significantly and TBUT increased significantly in both groups, especially in women of age 42–54 (both p < 0.0001). The global (corneal and conjunctival) staining score decreased significantly in both groups, but also more in women of age 42–54 years. No differences were observed between age groups for any of the variables measured, except for visual acuity. DED symptoms were consistently reported more frequently by the mixed hormonal status women, but also the effect of the treatment was more pronounced in this group.ConclusionsArtificial tears with trehalose and HA significantly improved the symptoms of DED in women aged 42–54 and ≥ 55 years. The decrease in symptoms was more pronounced in women of age 42–54 years, suggesting better mechanisms of recovery from inflammation and loss of ocular surface homeostasis.     

HR MAS 1H NMR and chemometrics as useful tool to assess the geographical origin of cocoa beans – Comparison with HR 1H NMR

Chocolate and cocoa-based products are among the goods with higher added value. A current trend of the cocoa market is to offer to the consumers high quality cocoa products, namely mono-origin cocoa. However, a reliable analytical method able to trace the geographical origin of cocoa is lacking. In this work we tested the capability of HR MAS ¹H NMR combined with chemometrics to assess the geographical origins of 60 fermented and dried cocoa beans of 23 different cocoa producing countries from the three major crop-growing areas (Africa, Central/South America, Asia/Oceania). Metabolic profiling was determined by HR MAS ¹H NMR directly on cocoa powder after the method optimization. The same samples were also subjected to extraction and analysis with HR ¹H NMR.HR MAS ¹H NMR, as ¹H NMR analysis, allowed the simultaneous detection of amino acids, polyalcohols, organic acids, sugars, methylxanthines, catechins. Moreover, HR MAS allows the detection of lipids, not present in the aqueous extract utilized for ¹H NMR. The data set obtained is therefore representative of all classes of cocoa compounds. Untargeted HR MAS ¹H NMR and ¹H NMR datasets were utilized as fingerprint of the samples and elaborated with multivariate statistical methods. A targeted quantitative approach of selected metabolites was possible only with HR ¹H NMR data, because HR MAS ¹H NMR does not give reliable quantitative results. All the approaches adopted showed a discrimination of the cocoa origins. HR MAS presents the advantages to obtain a very rapid picture of the samples, comprising both lipophilic and hydrophilic components, avoiding any sample manipulation.     

LC–MS/MS with atmospheric pressure chemical ionisation to study the effect of UV treatment on the formation of vitamin D3 and sterols in plants

Some plant species are known to cause calcium intoxification in grazing animals. This has been attributed to the presence of vitamin D₃-like activity. However, research into the presence of vitamin D₃ in plants has been limited. One reason for this may be limitations in the analytical methods available for unambiguous detection and quantification of vitamin D₃. This paper presents a new method for determining vitamin D₃ and its sterol precursors. The method is based on saponification and extraction followed by solid phase clean-up of the compounds from plant leaves and detection by APCI-MS. Recoveries ranged from 101% to 114% and precision from 3% to 12%. Detection limits were 2–8 ng/g fresh weight for the substances tested. In a pilot study we found that Solanum glaucohyllum Desf. and Solanum lycopersicum L. produced vitamin D₃ after UV-treatment. The preliminary results presented suggest that vitamin D₃ formation in plants is dependent on light exposure.