Longitudinal modelling of the exposure of young UK patients with PKU to acesulfame K and sucralose

Abstract

Artificial sweeteners are used in protein substitutes intended for the dietary management of inborn errors of metabolism (phenylketonuria, PKU) to improve the variety of medical foods available to patients and ensure dietary adherence to the prescribed course of dietary management. These patients can be exposed to artificial sweeteners from the combination of free and prescribed foods. Young children have a higher risk of exceeding acceptable daily intakes (ADI) for additives than adults, due to higher food intakes per kg body weight. Young patients with PKU aged 1-3 years can be exposed to higher levels of artificial sweeteners from these dual sources than normal healthy children and are at a higher risk of exceeding the ADI. Standard intake assessment methods are not adequate to assess the additive exposure of young patients with PKU. The aim of this study was to estimate the combination effect on the intake of artificial sweeteners and the impact of the introduction of new provisions for an artificial sweetener (sucralose, E955) on exposure of PKU patients using a validated probabilistic model. Food consumption data were derived from the food consumption survey data of healthy young children in the United Kingdom from the National Diet and Nutrition Survey (NDNS, 1992-2012). Specially formulated protein substitutes as foods for special medical purposes (FSMPs) were included in the exposure model to replace restricted foods. Inclusion of these protein substitutes is based on recommendations to ensure adequate protein intake in these patients. Exposure assessment results indicated the availability of sucralose for use in FSMPs for PKU leads to changes in intakes in young patients. These data further support the viability of probabilistic modelling as a means to estimate food additive exposure in patients consuming medical nutrition products.

Low-/No-Calorie Sweeteners: A Review of Global Intakes

“…A total of 19 European studies were identified from peer reviewed journals [51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69]. A further seven studies were identified from authoritative sources [70,71,72,73,74,75,76].…”

“…Amongst the studies conducted using the Tier 2/Tier 3 approach [58,60,63,64,65,66,67,69], the assessments utilized the full range of consumption values from individuals in the sample population, combined with a single value for the MPL (Tier 2) or actual usage levels (Tier 3), considering a single value (simple distribution) [58,63,69], or the full range of use levels (probabilistic) [60,64,65,66,67]. …”

“…Some of the more recently published studies also incorporated sweetener ‘occurrence’ or ‘presence’ data for the sweeteners of interest into the model [64,65,66,67,68,69,71,72]. This component of the assessment model involves accounting for the proportion of foods within a given food category which actually contain the sweetener of interest; there were several sources used for this information, namely market research databases, such as Mintel Global New Products database [68], health service records [65,67], food label surveys [64,66,69] or industry reports [52,71,72].…”

“…The high-level intake percentile has been most commonly established at the 95th percentile, which aligns with EFSA resources, such as the EFSA Comprehensive Database [79] and the FAIM Tool [4,6]. Several studies examined intakes in specific subgroups, including young children [52,53,56,60,61,62,64,70,71,72,73,74], diabetics [58,63], phenylketonurics (PKU) or subjects with severe cow’s milk protein allergy (CMPA) (who are consumers of FSMPs that are sweetened to increase palatability) [65,67]. …”

“…While some exceedances were identified in the scenarios conducted, these were typically reduced below the level of toxicological concern following assessment at more refined tiers of assessment for the various sweeteners examined. The exceptions to this were among young children with PKU, whereby high-level intakes of acesulfame-K exceeded the ADI at both Tiers 2 and 3 in two studies (up to 213% and 105.5%ADI at Tier 3) [65,67]. These assessments were modelled for this at-risk cohort using consumption data for healthy children from national dietary surveys as a surrogate, considering moderate and high-level adherence to clinical recommendations.…”