Actively Recruiting
Influence of Mediterranean Dietary Habits on Pregnancy and Foetus Development: the Role of Epigenetics and Inflammation
Led by Neuromed IRCCS · Updated on 2026-04-09
2000
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how following a Mediterranean-style diet during pregnancy may influence both the health of the mother and the development of the baby. This observational study focuses on understanding the diet's potential anti-inflammatory effects and epigenetic changes that could impact fetal growth and neurodevelopment. The study will establish a cohort of mother-newborn pairs to explore these relationships and their public health implications. Pregnant women within their first trimester will be enrolled and followed through pregnancy, with detailed dietary assessments using questionnaires and real-time recording methods at multiple gestational periods: 11-13, 20-22, and 30-32 weeks. Biological samples including venous blood during pregnancy and umbilical cord blood and saliva after delivery will be collected to analyze inflammation markers and epigenetic changes. The study aims to link maternal diet, inflammation, and newborn outcomes. Participants will undergo standard clinical and ultrasound examinations to assess fetal growth at specified gestational weeks. After birth, newborn growth and neurocognitive development will be followed up at 6, 12, 18, and 24 months using standardized measures including the Bayley Scales of Infant Development. Data on maternal health, pregnancy complications, and infant development will be collected alongside biological samples. The primary outcome is obstetric and perinatal complications over 9 months, with newborn growth and development also measured.
CONDITIONS
Brief Title
Mediterranean Diet on Pregnancy and Foetus Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women attending the Units of Obstetrics and Gynecology at Neuromed Clinical Research Network
- Women within the first trimester of pregnancy
- Women who express the willing to deliver at the aforementioned operating units
You will not qualify if you...
- Pregnancy with foetuses with known chromosomal or congenital malformation
- History of inflammatory disease
- Use of immunosuppressant drugs
- Pre-existing diabetes or hypertension
- Conception by heterologous artificial insemination
- Malabsorptive bariatric surgery
- Eating disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 13 weeks of pregnancy (first trimester)
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person) during the first prenatal visit
Duration - From enrollment through delivery (approximately 6 to 9 months)
Participants are observed during pregnancy with repeated assessments of dietary habits, maternal health, and fetal growth.
3 visits at 11-13, 20-22, and 30-32 gestational weeks, plus continuous dietary monitoring using Ecological Momentary Assessment
Duration - During pregnancy and at birth
Biological samples are collected from the mother during pregnancy and from the newborn at birth to analyze inflammation, epigenetics, and other molecular markers.
3 blood sample collections during pregnancy coinciding with visits plus collection of umbilical cord blood and saliva at delivery
Duration - Up to 24 months after birth
Newborn growth, development, and neurocognitive outcomes are assessed over the first two years of life.
4 developmental assessments at 6, 12, 18, and 24 months of age
Trial Site Locations
Total: 1 location
1
Istituto Clinico Mediterranea
Agropoli, SA, Italy, 84043
Actively Recruiting
Research Team
L
Licia Iacoviello, MD
S
Simona Esposito, msc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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