Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversidad de los Andes, Chile

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant women at 26-28 weeks of gestation

Singleton pregnancies

Pregnancies without fetal malformations

Disqualifiers

Pregnant women with pre-gestational and/or gestational diabetes mellitus

Pregnant women with obesity before or during pregnancy

Pregnant women with pre-eclampsia,

Pregnant women with pregnancy hypertensive syndrome

Trial design

Treatments tested in this trial

  • Extra Virgin Olive Oil (EVOO)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidad de los Andes, Chile

Lead sponsor

Universidad San Sebastián

Sponsor institution

Universidad San Sebastián

Collaborator