Evidence map›Paper›PMID 39033266›Full record

ArticleTrials2024

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.

Lisset Pantoja-Arévalo, Eva Gesteiro, Margarita Pérez-Ruiz, Jaime López-Seoane, Patricia Wusterhausen, Torsten Matthias, Rafael Urrialde, Marcela González-Gross

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05802017 (Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05802017 naunknown statusnot on this map

Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population

TypeinterventionalSponsorUniversidad Politecnica de MadridRan2022 to 2023Enrolled205ConditionsFood Allergy, Food Intolerance, Adverse Reaction to FoodArmsAllergen-specific substitute diet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Lisset Pantoja-ArévaloImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, 28040, Madrid, Spain. l.pantoja@upm.es.ORCID http://orcid.org/0000-0003-1469-1722
Eva GesteiroImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0002-9498-4228
Margarita Pérez-RuizImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0001-7240-2082
Jaime López-SeoaneImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0002-4597-2888
Patricia WusterhausenDepartment of Research and Development, Aesku.Diagnostics GmbH, 55234, Wendelsheim, Germany.
Torsten MatthiasDepartment of Research and Development, Aesku.Diagnostics GmbH, 55234, Wendelsheim, Germany.
Rafael UrrialdeDepartment of Genetics, Physiology and Microbiology, Faculty of Biological Sciences, Universidad Complutense de Madrid, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0003-0745-0816
Marcela González-GrossImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, 28040, Madrid, Spain.ORCID http://orcid.org/0000-0001-7757-3235

Funding

Universidad Politécnica de Madrid P2011600273
6 · The paper itself

Abstract

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. 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 registrationThe protocol has been approved by the Ethics Committee of the UPM (REF.20200602) and registered on ClinicalTrials.gov (NCT05802017).

Indexed as

AllergensFood HypersensitivityRandomized Controlled Trials as TopicAdultAlaskaFemaleHumansMaleTime FactorsTreatment OutcomeAllergensClinical trialDietDisease managementFood hypersensitivityFood intoleranceNutrition therapy

Identifiers

PMID39033266
PMCPMC11264907

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.