Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

The objective of this clinical trial is to know if supplementation with extra virgin olive oil (EVOO) during pregnancy, improves the maternal and neonatal lipoprotein profile, lipoprotein function, oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia (MSPH). The main questions to be answered are: 1. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy? 2. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy? The investigators will compare regular diet supplemented with EVOO vs. intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn. Participants: The recruited pregnant women will eat their normal diet (control group) or the same diet supplemented with 36 mL of EVOO daily (EVOO group). The protocol will be carried out from gestational week 28 to the end of pregnancy. A nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview. The recruited pregnant women will have the regular obstetric control every 4 weeks. At delivery, a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis.

NCT Number	NCT06567951
Lead Sponsor	Universidad de los Andes, Chile Collaborators: Universidad San Sebastián
Conditions	Pregnancy Related, Hypercholesterolemia
Enrollment	120 participants
Start Date	2024-09-10
Primary Completion	2025-03-01 (estimated)
Study Completion	2025-09-01 (estimated)
Updated on ClinicalTrials.gov	2024-08-23