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

Study Overview
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Brief Summary
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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
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Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.

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

Conditions
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Food Allergy, Food Intolerance, Adverse Reaction to Food

Intervention / Treatment
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* Other: Allergen-specific substitute diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergen-specific substitute diet<br>Participants follow a 4-month allergen-specific diet according to their immunology results. | Other: Allergen-specific substitute diet<br>* Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.<br>* Other names: IgG4 substitute diet;|
| No Intervention: Healthy diet<br>Participants follow a 4-month standard healthy diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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