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NOT YET RECRUITING
NCT06567951
NA

Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

Sponsor: Universidad de los Andes, Chile

View on ClinicalTrials.gov

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.

Official title: Maternal Supraphysiological Hypercholesterolemia: Extra Virgin Olive Oil as a Nutritional Intervention During Pregnancy to Reduce the Impact of This Maternal Condition

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-09-10

Completion Date

2025-09-01

Last Updated

2024-08-23

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Extra Virgin Olive Oil (EVOO)

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

Locations (1)

Clinica Universidad de los Andes

Santiago, Las Condes, Chile