Effects of the Mediterranean diet on pregnancy and fetal development
Influence of Mediterranean Dietary Habits on Pregnancy and Foetus Development: the Role of Epigenetics and Inflammation
This study is testing whether following the Mediterranean diet during pregnancy can improve outcomes for both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Neuromed IRCCS Academic / other |
| Locations | 1 site (Agropoli, SA) |
| Trial ID | NCT05403632 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how adherence to the Mediterranean diet (MeD) during pregnancy influences pregnancy outcomes and fetal development. The MeD is characterized by high consumption of plant foods, fish, and healthy fats, which may have anti-inflammatory properties and impact epigenetic mechanisms. The study aims to build a birth cohort to analyze the relationship between maternal diet and the health of newborns, focusing on potential long-term benefits for both mothers and children. By examining these connections, the research seeks to address public health concerns related to maternal nutrition and fetal growth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester who plan to deliver at the participating clinical units.
Not a fit: Patients with known chromosomal or congenital malformations in the fetus, or those with a history of inflammatory diseases or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how a Mediterranean diet during pregnancy may enhance fetal development and improve pregnancy outcomes.
How similar studies have performed: While there is growing interest in the effects of maternal nutrition on pregnancy outcomes, this specific focus on the Mediterranean diet is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Agropoli, SA
- Istituto Clinico Mediterranea — Agropoli, Sa, Italy (Recruiting)
Study contacts
- Principal investigator: Licia Iacoviello, MD — IRCCS Neuromed
- Study coordinator: Licia Iacoviello, MD
- Email: licia.iacoviello@moli-sani.org
- Phone: +39 3485108779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.