RecruitingNot ApplicableNCT05119868

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)


Sponsor

Federico II University

Enrollment

276 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 20 YearsMax Age: 35 Years

Inclusion Criteria1

  • \- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby

Exclusion Criteria15

  • 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.

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Interventions

OTHERNutritional intervention based on Mediterranean Diet

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.


Locations(2)

Department of Traslational Medical Science - University of Naples Federico II

Naples, Italy

Department of Traslational Medical Science

Naples, Italy

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NCT05119868


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