Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring A Multi-center Randomised-controlled Trial (the PREMEDI Project)

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 woman's 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 child's first two years.

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