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

Plain Language Summary

Simplified for easier understanding

This study examines whether following a Mediterranean diet during the first trimester of pregnancy can reduce the chances of a baby developing allergies. Allergies in children are increasing, and there is evidence that a mother's diet during pregnancy may influence how the baby's immune system develops. The study focuses on healthy women who are at higher risk of having a baby with allergies (atopy). You may be eligible if... - You are a healthy woman between 20 and 35 years old - You are in your first trimester of pregnancy - Your baby is considered at risk for developing allergies (atopy) You may NOT be eligible if... - You have an active infection, cancer, or significant gastrointestinal disease (including celiac disease, inflammatory bowel disease, or short bowel syndrome) - You have an immune deficiency or autoimmune disease - You follow a vegan diet - You are carrying twins - You have a genetic disorder, metabolic disorder, or neuropsychiatric condition - You have had previous abdominal surgery involving intestinal removal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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