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

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.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy; Food Intolerance; Adverse Reaction to Food
• Intervention / Treatment: Other: Allergen-specific substitute diet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisset S Pantoja Arevalo, MSc; Phone Number: +34602730244; Email: l.pantoja@upm.es
• Study Contact Backup: Name: Marcela Gonzalez Gross, Prof Dr; Email: marcela.gonzalez.gross@upm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Facultad de Ciencias de la Actividad Física y del Deporte
    • Contact: Marcela Gonzalez Gross, Prof Dr; Email: marcela.gonzalez.gross@upm.es
    • Contact: Lisset S Pantoja Arevalo, MSc; Email: l.pantoja@upm.es
    • Sub-Investigator: Lisset S Pantoja Arevalo, MSc
    • Sub-Investigator: Eva Gesteiro, PhD
    • Sub-Investigator: Rafael Urrialde, PhD
    • Principal Investigator: Marcela Gonzalez Gross, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Politecnica de Madrid
• Investigators: Study Chair: Lisset S Pantoja Arevalo, MSc, Universidad Politécnica de Madrid.; Principal Investigator: Marcela Gonzalez Gross, Prof Dr, Universidad Politécnica de Madrid.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): May 20, 2023
• Study Completion (Anticipated): June 20, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Signs and Symptoms, Digestive; Hypersensitivity; Food Hypersensitivity; Food Intolerance
• Other Study ID Numbers: P2011600273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No