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

ABSTRACT

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.

KEYWORDS:

• Predictive modelling
• artificial sweeteners
• steviol glycosides
• stevia
• exposure assessment
• children
• foods for special medical purposes
• phenylketonuria
• cows’ milk protein allergy
• CMPA

Acknowledgments

At the time of the research Aaron O’Sullivan was a full-time employee of Nutricia (Danone Trading Medical Nutrition BV) and studying part-time in University College Dublin, Ireland where the research was conducted. Aaron O’Sullivan is the author of this manuscript. Dr. Aideen McKevitt is the supervisor and proofread the manuscript. The collection of data for the National Preschool Nutrition Survey was supported by funding the Irish Department of Agriculture and Food under the Food for Health Research Initiative (2007–12). FACET was funded by the European Commission’s 7^th Framework Programme (FP7/2007–2013) [grant number 211686]. This work was supported by Nutricia (Danone Trading Medical Nutrition BV).

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by Nutricia (Danone Trading Medical Nutrition BV); This work was supported by the FACET project funded as part of the European Commission’s 7th Framework Programme (FP7/2007–2013) [211686]; Irish Department of Agriculture and Food under the Food for Health Research Initiative [2007–12].