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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05802017
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universidad Politecnica de Madrid
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lisset S Pantoja Arevalo, MScMarcela Gonzalez Gross, Prof Dr
Principal Investigator Affiliation Universidad Politecnica de MadridUniversidad Politecnica de Madrid
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy, Food Intolerance, Adverse Reaction to Food
Additional Details

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

Arms & Interventions

Arms

Experimental: Allergen-specific substitute diet

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

No Intervention: Healthy diet

Participants follow a 4-month standard healthy diet.

Interventions

Other: - Allergen-specific substitute diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Madrid, Spain

Status

Recruiting

Address

Facultad de Ciencias de la Actividad Física y del Deporte

Madrid, , 28040

Site Contact

Lisset S Pantoja Arevalo, MSc

[email protected]

+34602730244

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