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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05802017
Enrollment
205
Registered
2023-04-06
Start date
2022-04-04
Completion date
2023-06-20
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Reaction to Food, Food Allergy, Food Intolerance

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.

Interventions

OTHERAllergen-specific substitute diet

Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.

Sponsors

Universidad Politecnica de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.4-month interventionImmunoglobulin G4 and E reported in kilounits per liter through HELIA® Helmed Line Immunoassay.

Secondary

MeasureTime frameDescription
Body composition in sedentary and physically active population.4-month interventionWeight 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.4-month interventionMaximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.
General health in subjects with subjective symptoms of adverse reactions to food.4-month interventionHealth measured using number of cells reported in x10\^6/mm\^3 through spectrometry-flow cytometry Smty®.

Countries

Spain

Contacts

Primary ContactLisset S Pantoja Arevalo, MSc
l.pantoja@upm.es+34602730244
Backup ContactMarcela Gonzalez Gross, Prof Dr
marcela.gonzalez.gross@upm.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026