Actively Recruiting

Age: 18Years - 50Years
FEMALE
NCT05403632

Mediterranean Diet on Pregnancy and Foetus Development

Led by Neuromed IRCCS · Updated on 2026-04-09

2000

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mediterranean Diet on Pregnancy and Foetus Development

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women attending the Units of Obstetrics and Gynecology at Neuromed Clinical Research Network
  • Within the first trimester of pregnancy
  • Willing to deliver at the specified obstetrics units
Not Eligible

You will not qualify if you...

  • Pregnancy with fetuses having known chromosomal or congenital malformations
  • 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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Istituto Clinico Mediterranea

Agropoli, SA, Italy, 84043

Actively Recruiting

Loading map...

Research Team

L

Licia Iacoviello, MD

CONTACT

S

Simona Esposito, msc

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here