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

Sponsor
Universidad Politecnica de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT05802017
Collaborator
(none)
205
Enrollment
1
Location
2
Arms
14.5
Anticipated Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Allergen-specific substitute diet
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
205 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
Jun 20, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Physical condition in sedentary and physically active population. [4-month intervention]

      Maximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.

    3. 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®.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Facultad de Ciencias de la Actividad Física y del Deporte Madrid Spain 28040

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marcela Gonzalez Gross, Prof. Dr., Universidad Politecnica de Madrid
    ClinicalTrials.gov Identifier:
    NCT05802017
    Other Study ID Numbers:
    • P2011600273
    First Posted:
    Apr 6, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Food Hypersensitivity
    Food Intolerance

    Study Results

    No Results Posted as of Apr 6, 2023