Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy

Condition(s) studied

Investigational drug(s) / intervention(s)

Natural Non-Alkalized Cocoa: Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.

Polyphenol-Rich Dietary Counseling: Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.

Study summary

This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes.

Pregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role.

Pregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations.

The intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes.

The aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.

Eligibility

Primary outcome measure(s)

• Change in serum sVCAM-1 concentration — Baseline, 24-28 weeks, and 32-36 weeks of gestation
  Change in serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levels from baseline to 24-28 weeks of gestation, measured in \[ng/mL\].
• Change in serum sFlt-1/PlGF ratio — Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
  Change in the soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1/PlGF) ratio from baseline to 24-28 weeks and 32-36 weeks of gestation.
• Change in serum nitric oxide concentration — Baseline, 24-28 weeks, and 32-36 weeks of gestation.
  Change in serum nitric oxide (NO) concentration from baseline to 24-28 weeks and 32-36 weeks of gestation, measured in \[pg/mL\].
• Change in serum IL-6 concentration — Baseline, 24-28 weeks, and 32-36 weeks of gestation
  Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in \[pg/mL\].

Trial sites (1)

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