NCT05119868Completed
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 276 (actual)
- First submitted
- 3 Nov 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 10 Jan 2025
- Lead sponsor
- Federico II University
- Diseases
- Obesity
- NCT number
- NCT05119868
What you commit to
- Study type: Interventional
- Participants enrolled: 276
- From 2 Nov 2021 to the primary completion date, 10 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- concomitant presence of neuropsychiatric disorders;
- concomitant presence of central nervous system disorders;
- concomitant presence of genetic disorders;
- concomitant presence of metabolic disorders.
Other illness
- history of abdominal surgery with gastrointestinal resection;
Other
- vegan diet;
- twin pregnancy;
Who the study is looking for
- \- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby
Age in the registry: 20 years to 35 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Traslational Medical Science Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Department of Traslational Medical Science - University of Naples Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.