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

ABSTRACT

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.

KEYWORDS:

• Probabilistic modelling
• young patients
• foods for special medical purposes
• phenylketonuria
• cow’s milk protein allergy
• simplified exposure tool in medical nutrition (SETIM)

Acknowledgements

Permission to use the data collected in the UK’s National Diet and Nutrition Survey (NDNS) for the study period was kindly granted by the Economic and Social Data Service. 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 7th Framework Programme (FP7/2007–2013) [grant number 211686]. Refined specific sweetener usage data were kindly provided by Nutricia (Danone Trading Medical Nutrition BV).

Disclosure statement

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. At the time of the research Cian O’Mahony was a full-time employee of Creme Global, Ireland. Dr. Leo Meunier (Toxicologist) and Nik Loveridge (Dietitian) are full-time employees of Danone. This work was supported by Nutricia (Danone Trading Medical Nutrition BV).

Additional information

Funding

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 7th Framework Programme (FP7/2007–2013) [grant number 211686].