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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05802017
Other study ID # P2011600273
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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