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Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

ConditionsPregnancy RelatedHypercholesterolemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Extra Virgin Olive Oil (EVOO)

    Dietary supplement

    This is the first time that prengnt women with maternal supraphysiological hypercholesterolemia will be suplemented with EVOO during pregnancy. The intervention will be daily EVOO suplementation (36mL) form gestational week 28 until delivery

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control group (without EVOO supplementation)No intervention 0 interventions
Group B: EVOO group (with EVOO supplementation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
48 weeks after the end of pregnancy or 60 weeks after randomization
2

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

Time frame
48 weeks after the end of pregnancy or 60 weeks after randomization
3

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

Time frame
10 weeks after the end of each pregnancy or 22 weeks after randomization.

Secondary outcomes

1

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

Time frame
48 week after pregnancy or 60 weeks after randomization
2

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.

Time frame
The adherence to mediterranean diet will be evaluated 4, 8 and 12 weeks after randomization
3

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.

Time frame
The FFQ will be evaluated 4, 8 and 12 weeks after randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de los Andes, Chile

Lead sponsor

Universidad San Sebastián

Sponsor institution

Universidad San Sebastián

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: