Studying How Following a Mediterranean Diet During Early Pregnancy Affects Allergy Development in Children by Age 2
Led by Federico II University · Updated on 2026-02-12
276
Participants Needed
2
Research Sites
60 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying how following the Mediterranean Diet during pregnancy might influence the development of allergies in children by age two. This trial focuses on healthy pregnant women between 20 and 35 years old who have a higher risk of having babies with allergic conditions. The Mediterranean Diet is known for its healthy nutrients that may affect the immune system, and this study aims to see if it can help prevent allergies in offspring.
Participants are randomly assigned to one of two groups. One group receives standard pregnancy care plus personalized nutritional counseling based on the Mediterranean Diet, tailored by certified dietitians according to each womans pre-pregnancy weight, height, and pregnancy trimester. The other group receives only the usual obstetrical and gynecological follow-up without the dietary counseling. This randomized controlled trial monitors the effects during pregnancy and after birth.
During the study, researchers will assess the children for allergic disorders at 24 months of age. They will also track maternal weight gain, pregnancy and perinatal complications, neonatal birth weight, and growth and health in the offspring during their first two years. Additional evaluations include maternal and child gut microbiome features, breastfeeding duration and breast milk composition, and gene regulation related to immune and metabolic pathways. The study includes a digital app validation and spans from enrollment through the childs first two years.
CONDITIONS
Brief Title
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Research Team
R
Roberto Berni Canani
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History of abdominal surgery with gastrointestinal resection
Neuropsychiatric disorders
Central nervous system disorders
Following a vegan diet
Twin pregnancy
Genetic disorders
Metabolic disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - From enrollment until delivery
Participants follow a personalized nutritional counseling and tailored diet based on the Mediterranean dietary pattern during pregnancy, alongside standard obstetrical and gynecological follow-up.
Regular visits with certified dietitians and obstetrical follow-up
Long-term Monitoring
Duration - 24 months from birth
Participants and their offspring are monitored for allergy onset and other health outcomes up to 24 months after birth.
Periodic visits during the first 2 years of life for the offspring
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study).
Serena Coppola, Lorella Paparo, Lorenzo Chiariotti...