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Background <p>During human pregnancy, plasma total cholesterol (TC) levels increase as pregnancy progresses, a phenomenon referred to as maternal physiological hypercholesterolemia (MPH), where maternal levels of TC at term during pregnancy are ≤ 280 mg/dL. However, when pregnancy-associated hypercholesterolemia exceeds this physiological adaptation (&gt; 280 mg/dL), is defined as maternal supraphysiological hypercholesterolemia (MSPH). MSPH has been associated with placental vascular dysfunction; increased maternal, placental, and neonatal oxidative stress; impaired placental cholesterol trafficking; increased early atherosclerotic lesions in neonates and children from MSPH; and increased cardiovascular risk in adults born from MSPH pregnancies. Despite this information, no information about possible therapies or treatments is available to improve the deleterious effects associated with MSPH.</p> Methods and results <p>A total of 120 pregnant women will be recruited for regular obstetric control from week 24 to week 27 of gestation. Sixty of these women will be supplemented with 36 mL (3 tablespoons) of EVOO daily (EVOO group) until term. Moreover, an equivalent group of women without EVOO supplementation will be considered the control group. The primary outcome will be to assess the lipid profile, lipoprotein function and oxidative status at term in maternal and umbilical cord blood. Secondary outcomes will determine markers of endothelial dysfunction, adherence to Mediterranean diet and EVOO supplementation.</p> Discussion <p>This study will determine the effect of EVOO dietary supplementation on MSPH pregnancies. The protocol is intended to set the stage for future investigation to evaluate effective intervention on MSPH women.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT06567951 (2024–08–23).</p>

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MaterLIP clinical trial design: extra virgin olive oil supplementation in pregnancies with increased cholesterol levels

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月6日

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  • Reyna Peñailillo,
  • Patricia Valdebenito,
  • Sebastián E. Illanes,
  • Andrea Leiva

摘要

Background

During human pregnancy, plasma total cholesterol (TC) levels increase as pregnancy progresses, a phenomenon referred to as maternal physiological hypercholesterolemia (MPH), where maternal levels of TC at term during pregnancy are ≤ 280 mg/dL. However, when pregnancy-associated hypercholesterolemia exceeds this physiological adaptation (> 280 mg/dL), is defined as maternal supraphysiological hypercholesterolemia (MSPH). MSPH has been associated with placental vascular dysfunction; increased maternal, placental, and neonatal oxidative stress; impaired placental cholesterol trafficking; increased early atherosclerotic lesions in neonates and children from MSPH; and increased cardiovascular risk in adults born from MSPH pregnancies. Despite this information, no information about possible therapies or treatments is available to improve the deleterious effects associated with MSPH.

Methods and results

A total of 120 pregnant women will be recruited for regular obstetric control from week 24 to week 27 of gestation. Sixty of these women will be supplemented with 36 mL (3 tablespoons) of EVOO daily (EVOO group) until term. Moreover, an equivalent group of women without EVOO supplementation will be considered the control group. The primary outcome will be to assess the lipid profile, lipoprotein function and oxidative status at term in maternal and umbilical cord blood. Secondary outcomes will determine markers of endothelial dysfunction, adherence to Mediterranean diet and EVOO supplementation.

Discussion

This study will determine the effect of EVOO dietary supplementation on MSPH pregnancies. The protocol is intended to set the stage for future investigation to evaluate effective intervention on MSPH women.

Trial registration

ClinicalTrials.gov Identifier: NCT06567951 (2024–08–23).