Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Recruiting · NCT05119868 · Interventional (participants receive a specific treatment) · Lead sponsor: Federico II University
View the official record on ClinicalTrials.gov →Interventions studied
Nutritional intervention based on Mediterranean Diet
What this trial is about
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.
Who can take part
Age range
20 Years to 35 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby
Exclusion criteria
- concomitant presence of infections;
- concomitant presence of malignancies;
- concomitant presence of major gastrointestinal malformations;
- concomitant presence of immunodeficiencies;
- concomitant presence of autoimmune diseases;
- concomitant presence of chronic inflammatory bowel diseases;
- concomitant presence of functional gastrointestinal disorders;
- concomitant presence of celiac disease;
- history of abdominal surgery with gastrointestinal resection;
- concomitant presence of neuropsychiatric disorders;
- concomitant presence of central nervous system disorders;
- vegan diet;
- twin pregnancy;
- concomitant presence of genetic disorders;
- concomitant presence of metabolic disorders.
Where it is running
2 locations listed.
- Department of Traslational Medical Science - University of Naples Federico II - Naples, Italy
- Department of Traslational Medical Science - Naples, Italy