Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorFederico II University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

concomitant presence of infections;

concomitant presence of malignancies;

concomitant presence of major gastrointestinal malformations;

concomitant presence of immunodeficiencies;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutritional intervention based on Mediterranean Diet

    Other intervention

    A personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians.

Treatment groups

276 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Occurrence of allergic disorders at 24 months of age in the offspring

The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring

Time frame
24 months from birth

Secondary outcomes

1

Maternal weight gain

The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain

Time frame
From enrollment until delivery
2

Pregnancy complications occurrence

The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence

Time frame
From enrollment until delivery
3

Perinatal complications occurrence

The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence

Time frame
Delivery
4

Neonatal birth weight

The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices

Time frame
Delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.