RT Journal Article
T1 The multifactorial approach and the food allergen-specific substitutive diet as a tool to manage and ameliorate adverse reactions to foodstuffs in adulthood: study protocol for a randomized controlled trial—the ALASKA study
A1 Pantoja Arévalo, Lisset
A1 Gesteiro, Eva
A1 Pérez Ruiz, Margarita
A1 López Seoane, Jaime
A1 Wusterhausen, Patricia
A1 Matthias, Torsten
A1 Urrialde De Andrés, Rafael
A1 González Gross, Marcela
AB BackgroundAdverse reactions to foodstuffs (ARFS), specifically food allergy (FA) and food intolerance (FI), are increasing worldwide and represent a major public health concern. Thus, ARFS management, its identification, evaluation, and intervention, must provide a comprehensive solution.Objectives(a) To develop a multifactorial strategy for ARFS management in adults with FA and/or FI; (b) to describe the multiple influential variables in ARFS within the realm of ARFS management; and (c) to design a personalized food allergen-specific substitutive diet (FASSD), as a 6-month dietary treatment option for adults with ARFS and as a component of ARFS management.MethodsThe ALASKA study will consider the following main variables as part of the ARFS management: (1) demographics and clinical information; (2) symptomatology, food and beverages intake and physical activity; (3) hematobiochemical study; (4) immunology; (5) enzymatic activity; (6) anthropometry, body composition, and physical fitness; (7) QoL; (8) 6-month intervention; (9) end of the study; and (10) other assessments. The FASSD will be designed with special emphasis on the commonly lacking micronutrients in the ARFS population: niacin, Mg, K, P, Ca, Zn, B12, folate, Fe, and fiber.DiscussionThe ALASKA study protocol has been developed as a global strategy to manage and evaluate ARFS in Spanish adults older than 18 years of age. Approaching ARFS with multiple assessments, as influencing factors, will lead to a novel strategy for ARFS management. The FASSD has been designed as a personalized tool to avoid crucial micronutrient deficiencies that a current strict food allergen avoidance or elimination diet may provoke.Trial registrationThe protocol has been approved by the Ethics Committee of the UPM (REF.20200602) and registered on ClinicalTrials.gov (NCT05802017).
PB Springer
SN 1745-6215
YR 2024
FD 2024
LK https://hdl.handle.net/20.500.14352/117986
UL https://hdl.handle.net/20.500.14352/117986
LA eng
NO Pantoja-Arévalo, L., Gesteiro, E., Pérez-Ruiz, M. et al. The multifactorial approach and the food allergen-specific substitutive diet as a tool to manage and ameliorate adverse reactions to foodstuffs in adulthood: study protocol for a randomized controlled trial—the ALASKA study. Trials 25, 494 (2024). https://doi.org/10.1186/s13063-024-08307-2
NO This research was partially funded by own funds of the ImFINE Research Group. Additional funding from the Instituto de Salud Carlos III through CIBEROBN (CB12/03/30038), which is co-funded by the European Regional Development Fund. Lisset Pantoja-Arévalo is supported by the Universidad Politécnica de Madrid by means of a predoctoral contract (project number: P2011600273). This project was funded by Aesku.Diagnostics GmbH through an agreement with the Universidad Politécnica de Madrid.
NO ImFINE Research Group
NO Instituto de Salud Carlos III
NO European Commission
NO Universidad Politécnica de Madrid
NO Aesku.Diagnostics GmbH
DS Docta Complutense
RD 16 dic 2025