RecruitingNCT05403632

Mediterranean Diet on Pregnancy and Foetus Development

Influence of Mediterranean Dietary Habits on Pregnancy and Foetus Development: the Role of Epigenetics and Inflammation


Sponsor

Neuromed IRCCS

Enrollment

2,000 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The Mediterranean-style diet has been associated with longevity, long-life wellbeing, lower risk of cardiovascular disease, cancer, obesity, and metabolic syndrome. Research is pointing to the benefits that MeD could have in pregnant. Pregnancy is a very complex period and recently, the attention has been focused on the possibility that healthy dietary patterns positively influence pregnancy and the development of organs in the offspring. The mechanisms through which MeD influences pregnancy and fetal growth may partly depend on its antinflammatory properties and possibly on changes in epigenetic mechanisms. Systemic inflammation might contribute to the association between maternal obesity and less favorable neurodevelopmental outcomes. The investigators aim to define how maternal adhesion to MeD may affect pregnancy and new-born development, hence representing a notable burden from a public health and social perspective. Main objective of this project is to build up a birth cohort suitable to investigate the role of maternal dietary habits on maternal and new-born health, with special focus on MeD and its possible mechanism of action through epigenetic and inflammation changes. To establish a mother/new-born cohort, collect detailed information on maternal dietary habits and set-up a biobank of biological samples to evaluate the association between dietary habits and pregnancy outcomes. The investigators will recruit 2000 pairs (mother, new-born) in different obstetrics departments. To investigate the association between maternal dietary habits, foetal growth and offspring development and possible mediation by the inflammation profile of the mother. To understand whether maternal dietary habits are associated with epigenetic changes in the offspring and if this process is driven by the inflammation profile of the mother. Venous blood samples will be obtained at the baseline and at each gestational period for ultrasound at 11-13 gestational weeks, 20-22 weeks and 30-32 weeks. Women will be followed-up with standard clinical and 2D ultrasound examinations at gestational weeks 11-13, 20-22 and 30-32 to evaluate the fetal growth. Offspring development will be assessed at 6, 12, 18, 24 months of age. After delivery, the investigators will collect umbilical cord blood and saliva samples from new-born using standard procedures. To understand if new-born epigenetics is associated with infant physical and neurocognitive development in the following 2 years.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether following a Mediterranean diet during pregnancy — rich in vegetables, fruits, fish, and olive oil — improves outcomes for both the mother and developing baby. Pregnant women will be guided to follow this diet and their health will be monitored. You may be eligible if: - You are 18 to 50 years old and pregnant - You are in your first trimester of pregnancy - You plan to deliver at one of the participating clinics in Italy You may NOT be eligible if: - Your baby has a known chromosomal or birth defect - You have a history of inflammatory disease - You take immunosuppressive medications - You have pre-existing diabetes or high blood pressure - Your pregnancy was conceived through donor egg IVF - You have had bariatric surgery or have an eating disorder 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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Locations(1)

Istituto Clinico Mediterranea

Agropoli, SA, Italy

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NCT05403632


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