Food AllergyNCT05802017
Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
A study testing Allergen-specific substitute diet in people with Food Allergy and Food Intolerance, run by Universidad Politecnica de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Food Intolerance, Adverse Reaction to Food
- What is being tested?
- Allergen-specific substitute diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diseases and symptomatology associated to ARF.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Marcela Gonzalez Gross, Prof Dr contact
Spain1 site, 1 recruiting
- Recruiting
Facultad de Ciencias de la Actividad Física y del Deporte
Madrid, 28040
Lisset S Pantoja Arevalo, MSc, l.pantoja@upm.es
Marcela Gonzalez Gross, Prof Dr, marcela.gonzalez.gross@upm.es
About this study
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.
Read the detailed description
Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.
- Conditions
- Food Allergy, Food Intolerance, Adverse Reaction to Food
- Being tested
- Allergen-specific substitute diet
- Medical subject headings
- Food Hypersensitivity, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen-specific substitute dietOther
Also called Substitute diet, IgG4 substitute diet
Substitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value.
| Study group | Role | What they receive |
|---|---|---|
| Allergen-specific substitute diet | Experimental | Participants follow a 4-month allergen-specific diet according to their immunology results. Receives: Other: Allergen-specific substitute diet |
| Healthy diet | No intervention | Participants follow a 4-month standard healthy diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-month intervention
Secondary outcomes (3)
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.
Measured: 4-month intervention
Physical condition in sedentary and physically active population.
Maximum rate of oxygen reported in VO₂max using GE Olmeda TuffSat®.
Measured: 4-month intervention
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®.
Measured: 4-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start4 Apr 2022
- Primary completion20 May 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Gonzalez Gross, Universidad Politecnica de Madrid
- Investigators
- Lisset S Pantoja Arevalo, MSc, Study chair, Universidad Politecnica de MadridMarcela Gonzalez Gross, Prof Dr, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802017
- Sponsor's protocol ID
- P2011600273
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39033266
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population
- ClinicalTrials.gov ID
- NCT05802017
- Acronym / sponsor ID
- P2011600273
- Conditions
- Food Allergy, Food Intolerance, Adverse Reaction to Food
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergen-specific substitute diet | Experimental | Other: Allergen-specific substitute dietParticipants follow a 4-month allergen-specific diet according to their immunology results. |
| Healthy diet | No intervention | –Participants follow a 4-month standard healthy diet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diseases and symptomatology associated to ARF.
Key exclusion criteria (7 listed)
- Participation in other study.
- Pregnancy.
- Antibiotic treatment.
- Active Helicobacter pylori infection.
- Antidepressant, sleeping pill, or anxiolytic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen-specific substitute dietAlso: Substitute diet, IgG4 substitute dietSubstitution of IgG4 allergen-specific reactive foodstuffs for equivalent foodstuffs with similar nutritional value. | Other | Allergen-specific substitute diet |
Primary outcome
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food.
Time frame: 4-month intervention
Immunoglobulin G4 and E reported in kilounits per liter through HELIA® Helmed Line Immunoassay.
3 secondary outcomes
Body composition in sedentary and physically active population.
Time frame: 4-month intervention
Physical condition in sedentary and physically active population.
Time frame: 4-month intervention
General health in subjects with subjective symptoms of adverse reactions to food.
Time frame: 4-month intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 39033266Pantoja-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Gonzalez Gross, Prof Dr contact
Lisset S Pantoja Arevalo, MSc study chair
Universidad Politecnica de Madrid
Marcela Gonzalez Gross, Prof Dr principal investigator
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen-specific substitute diet in people with Food Allergy and Food Intolerance, run by Universidad Politecnica de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisset S Pantoja Arevalo, MSc (+34602730244, l.pantoja@upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin G4 and E response in subjects with subjective symptoms of adverse reactions to food. (time frame: 4-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.