NCT05403632 Mediterranean Diet on Pregnancy and Foetus Development
| NCT ID | NCT05403632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuromed IRCCS |
| Condition | Pregnancy Outcomes |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2023-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Licia Iacoviello, MD
PRINCIPAL INVESTIGATOR
IRCCS Neuromed
Frequently Asked Questions
Who can join the NCT05403632 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Pregnancy Outcomes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05403632 currently recruiting?
Yes, NCT05403632 is actively recruiting participants. Contact the research team at licia.iacoviello@moli-sani.org for enrollment information.
Where is the NCT05403632 trial being conducted?
This trial is being conducted at Agropoli, Italy.
Who is sponsoring the NCT05403632 clinical trial?
NCT05403632 is sponsored by Neuromed IRCCS. The principal investigator is Licia Iacoviello, MD at IRCCS Neuromed. The trial plans to enroll 2,000 participants.