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

Not Applicable

Recruiting

• Conditions: Food Intolerance; Food Allergy; Adverse Reaction to Food
• Interventions: Other: Allergen-specific substitute diet

• Registration Number: NCT05802017
• Lead Sponsor: Universidad Politecnica de Madrid

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.

Detailed Description

Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2022-12-05
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-05-20
• Study Completion: 2023-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Diseases and symptomatology associated to ARF.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Allergen-specific substitute diet	Allergen-specific substitute diet	Participants follow a 4-month allergen-specific diet according to their immunology results.

Primary Outcome Measures

Name	Time	Method
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.	4-month intervention	Immunoglobulin G4 and E reported in kilounits per liter through HELIA® Helmed Line Immunoassay.

Secondary Outcome Measures

Name	Time	Method
Physical condition in sedentary and physically active population.	4-month intervention	Maximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.
General health in subjects with subjective symptoms of adverse reactions to food.	4-month intervention	Health measured using number of cells reported in x10\^6/mm\^3 through spectrometry-flow cytometry Smty®.
Body composition in sedentary and physically active population.	4-month intervention	Weight and Height will be combined to report BMI in kg/m\^2 through Tanita equipment model MC-780MA.

Trial Locations

Locations (1)

Facultad de Ciencias de la Actividad Física y del Deporte; 🇪🇸 Madrid, Spain