Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels
NCT Number: NCT06567951
Acronym: MaterLIP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Related|Hypercholesterolemia
Interventions: DIETARY_SUPPLEMENT: Extra Virgin Olive Oil (EVOO)
Sponsor: Universidad de los Andes, Chile
Collaborators: Universidad San Sebastián
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2025-09-01
Locations: Clinica Universidad de los Andes, Santiago, Las Condes, Chile

Summary:
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.

Primary Outcome Measures: Lipoprotein function, At the end of pregnancy lipoprotein function determined as conjugated dienes formation (concentration vs time) will be evaluated by ultraviolet absorbance in lipoproteins isolated from maternal and umbilical cord blood, 48 weeks after the end of pregnancy or 60 weeks after randomization|Oxidative status, At the end of pregnancy oxidative status determined as concentration of oxidized LDL (mg/dL) will be evaluated by ELISA in maternal and umbilical cord blood, 48 weeks after the end of pregnancy or 60 weeks after randomization|Lipid profile, At the end of pregnancy, lipoprotein profile determined as concentration of total cholesterol, LDL, HDL and triglycerides (mg/dL) will be evaluated in the clinical laboratory in maternal and umbilical cord blood, 10 weeks after the end of each pregnancy or 22 weeks after randomization.
Secondary Outcome Measures: Markers of endothelial dysfunction, At the end of pregnancy, markers of endothelial dysfunction determined as levels of soluble VCAM (ng/mL) will be assayed by ELISA in maternal and umbilical blood as well as in placental vessels, 48 week after pregnancy or 60 weeks after randomization|Determination of adherence to a mediterranean diet, Adherence to mediterranean diet, which includes EVOO consumption, will be assayed by the mediterranean diet adherence screener (MEDAS). The adherence will be considered Good, Regular, or Bad according to established and published criteria of MEDAS., The adherence to mediterranean diet will be evaluated 4, 8 and 12 weeks after randomization|Determination of adherence to EVOO supplementation by food frequency questionnaire, Adherence to the EVOO supplementation will be evaluated by food frequency questionnaire (FFQ). The adherence will be considered Good, if questionaries indicated a daily EVOO consumption over 26 g/day, 5 to 7 times per week. As Regular, if daily EVOO consumption was over 26 g/day, but only 3 or 4 times per week, and Bad, if daily EVOO consumption was lower than 26 g/day or lower than 3 times per week., The FFQ will be evaluated 4, 8 and 12 weeks after randomization.