OBJECTIVE: (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.
CONCLUSIONS: 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.
BACKGROUND: The protocol has been approved by the Ethics Committee of the UPM (REF.20200602) and registered on ClinicalTrials.gov (NCT05802017).
目的:(a)为有FA和/或FI的成年人制定ARFS管理的多因素策略;(b)描述ARFS管理领域内ARFS的多个影响变量;(c)设计个性化的食物过敏原特异性替代饮食(FASSD),作为ARFS成人的6个月饮食治疗选择和ARFS管理的组成部分。
方法:ALASKA研究将考虑以下主要变量作为ARFS管理的一部分:(1)人口统计学和临床信息;(2)症状学,食品和饮料摄入和身体活动;(3)血液生化研究;(4)免疫学;(5)酶活性;(6)人体测量学,身体成分,和身体素质;(7)QoL;(8)6个月的干预;(9)研究结束;(10)其他评估。FASSD的设计将特别强调ARFS人群中普遍缺乏的微量营养素:烟酸,Mg,K,P,Ca,Zn,B12叶酸,Fe,和纤维。
结论:ALASKA研究方案已被开发为管理和评估18岁以上西班牙成年人ARFS的全球战略。通过多种评估接近ARFS,作为影响因素,将导致ARFS管理的新战略。FASSD已被设计为一种个性化的工具,以避免目前严格的食物过敏原避免或消除饮食可能引起的关键的微量营养素缺乏。
背景:该方案已获得UPM伦理委员会(REF.20200602)的批准,并在ClinicalTrials.gov(NCT05802017)上注册。