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

Primary Purpose

Food Allergy, Food Intolerance, Adverse Reaction to Food

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Allergen-specific substitute diet
Sponsored by
Universidad Politecnica de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Facultad de Ciencias de la Actividad Física y del DeporteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Allergen-specific substitute diet

Healthy diet

Arm Description

Participants follow a 4-month allergen-specific diet according to their immunology results.

Participants follow a 4-month standard healthy diet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Physical condition in sedentary and physically active population.
Maximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.
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®.

Full Information

First Posted
December 5, 2022
Last Updated
March 24, 2023
Sponsor
Universidad Politecnica de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05802017
Brief Title
Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
Official Title
Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Politecnica de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Food Intolerance, Adverse Reaction to Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allergen-specific substitute diet
Arm Type
Experimental
Arm Description
Participants follow a 4-month allergen-specific diet according to their immunology results.
Arm Title
Healthy diet
Arm Type
No Intervention
Arm Description
Participants follow a 4-month standard healthy diet.
Intervention Type
Other
Intervention Name(s)
Allergen-specific substitute diet
Other Intervention Name(s)
Substitute diet, IgG4 substitute diet
Intervention Description
Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.
Primary Outcome Measure Information:
Title
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.
Description
Immunoglobulin G4 and E reported in kilounits per liter through HELIA® Helmed Line Immunoassay.
Time Frame
4-month intervention
Secondary Outcome Measure Information:
Title
Body composition in sedentary and physically active population.
Description
Weight and Height will be combined to report BMI in kg/m^2 through Tanita equipment model MC-780MA.
Time Frame
4-month intervention
Title
Physical condition in sedentary and physically active population.
Description
Maximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.
Time Frame
4-month intervention
Title
General health in subjects with subjective symptoms of adverse reactions to food.
Description
Health measured using number of cells reported in x10^6/mm^3 through spectrometry-flow cytometry Smty®.
Time Frame
4-month intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisset S Pantoja Arevalo, MSc
Phone
+34602730244
Email
l.pantoja@upm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Marcela Gonzalez Gross, Prof Dr
Email
marcela.gonzalez.gross@upm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisset S Pantoja Arevalo, MSc
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcela Gonzalez Gross, Prof Dr
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Ciencias de la Actividad Física y del Deporte
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisset S Pantoja Arevalo, MSc
Email
l.pantoja@upm.es
First Name & Middle Initial & Last Name & Degree
Marcela Gonzalez Gross, Prof Dr
Email
marcela.gonzalez.gross@upm.es
First Name & Middle Initial & Last Name & Degree
Lisset S Pantoja Arevalo, MSc
First Name & Middle Initial & Last Name & Degree
Eva Gesteiro, PhD
First Name & Middle Initial & Last Name & Degree
Rafael Urrialde, PhD
First Name & Middle Initial & Last Name & Degree
Marcela Gonzalez Gross, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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