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

Abstract

Abstract Background Adverse 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. Methods The 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. Discussion The 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 registration The protocol has been approved by the Ethics Committee of the UPM (REF.20200602) and registered on ClinicalTrials.gov (NCT05802017).

Keywords

• Clinical trial
• Diet
• Disease management
• Food hypersensitivity
• Food intolerance
• Nutrition therapy