Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
1 other identifier
interventional
205
1 country
1
Brief Summary
Since the prevalence of adverse reactions to foodstuffs (ARFS) has been steadily increasing and has become an alarming health concern, the general objective of this study is to analyze the prevalence of ARFS in Spanish adults of different physical condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2022
CompletedFirst Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedApril 6, 2023
March 1, 2023
1.1 years
December 5, 2022
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.
Immunoglobulin G4 and E reported in kilounits per liter through HELIA® Helmed Line Immunoassay.
4-month intervention
Secondary Outcomes (3)
Body composition in sedentary and physically active population.
4-month intervention
Physical condition in sedentary and physically active population.
4-month intervention
General health in subjects with subjective symptoms of adverse reactions to food.
4-month intervention
Study Arms (2)
Allergen-specific substitute diet
EXPERIMENTALParticipants follow a 4-month allergen-specific diet according to their immunology results.
Healthy diet
NO INTERVENTIONParticipants follow a 4-month standard healthy diet.
Interventions
Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.
Eligibility Criteria
You may qualify if:
- Diseases and symptomatology associated to ARF.
You may not qualify if:
- Participation in other study.
- Pregnancy.
- Antibiotic treatment.
- Active Helicobacter pylori infection.
- Antidepressant, sleeping pill, or anxiolytic treatment.
- Job or lifestyle that potentially interferes with your regular sleep schedule.
- Active Cancer treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Facultad de Ciencias de la Actividad Física y del Deporte
Madrid, 28040, Spain
Related Publications (1)
Pantoja-Arevalo L, Gesteiro E, Perez-Ruiz M, Lopez-Seoane J, Wusterhausen P, Matthias T, Urrialde R, Gonzalez-Gross M. 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. 2024 Jul 20;25(1):494. doi: 10.1186/s13063-024-08307-2.
PMID: 39033266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lisset S Pantoja Arevalo, MSc
Universidad Politecnica de Madrid
- PRINCIPAL INVESTIGATOR
Marcela Gonzalez Gross, Prof Dr
Universidad Politecnica de Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 5, 2022
First Posted
April 6, 2023
Study Start
April 4, 2022
Primary Completion
May 20, 2023
Study Completion
June 20, 2023
Last Updated
April 6, 2023
Record last verified: 2023-03