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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802017
• Other study ID #: P2011600273
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: March 2023
• Source: Universidad Politecnica de Madrid
• Contact: Lisset S Pantoja Arevalo, MSc
• Phone: +34602730244
• Email: l.pantoja[@]upm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: June 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Food Intolerance

Intervention

Other:
• Allergen-specific substitute diet
Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.

Locations

Country	Name	City	State
Spain	Facultad de Ciencias de la Actividad Física y del Deporte	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Physical condition in sedentary and physically active population.	Maximum rate of oxygen reported in VO2max using GE Olmeda TuffSat®.	4-month intervention
Secondary	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