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

NCT ID: NCT05802017

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-06-20

Brief Summary

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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

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

Conditions

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Food Allergy Food Intolerance Adverse Reaction to Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Allergen-specific substitute diet

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

Group Type EXPERIMENTAL

Allergen-specific substitute diet

Intervention Type OTHER

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

Healthy diet

Participants follow a 4-month standard healthy diet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Allergen-specific substitute diet

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

Intervention Type OTHER

Other Intervention Names

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Substitute diet IgG4 substitute diet

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Politecnica de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Marcela Gonzalez Gross

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisset S Pantoja Arevalo, MSc

Role: STUDY_CHAIR

Universidad Politecnica de Madrid

Marcela Gonzalez Gross, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Universidad Politecnica de Madrid

Locations

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Facultad de Ciencias de la Actividad FĂ­sica y del Deporte

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Lisset S Pantoja Arevalo, MSc

Role: CONTACT

+34602730244

Marcela Gonzalez Gross, Prof Dr

Role: CONTACT

Facility Contacts

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Lisset S Pantoja Arevalo, MSc

Role: primary

Marcela Gonzalez Gross, Prof Dr

Role: backup

References

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Pantoja-Arevalo L, Gesteiro E, Perez-Ruiz M, Lopez-Seoane J, Wusterhausen P, Matthias T, Urrialde R, Gonzalez-Gross M. The multifactorial approach and the food allergen-specific substitutive diet as a tool to manage and ameliorate adverse reactions to foodstuffs in adulthood: study protocol for a randomized controlled trial-the ALASKA study. Trials. 2024 Jul 20;25(1):494. doi: 10.1186/s13063-024-08307-2.

Reference Type DERIVED
PMID: 39033266 (View on PubMed)

Other Identifiers

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P2011600273

Identifier Type: -

Identifier Source: org_study_id

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