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Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels

NCT06567951 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-23

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Universidad San Sebastián

    collaborator OTHER

  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Andrea Leiva, PhD · Universidad San Sebastian

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2025-03-01
Completion
2025-09-01

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567951 on ClinicalTrials.gov