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.
Pregnant women aged 18 years or older.
Singleton pregnancy.
Gestational age between 8 and 11 weeks at enrollment.
Receiving prenatal care within the Salamanca Health Area.
Medical or obstetric conditions that contraindicate dietary modifications.
Active metabolic, renal, or hepatic disease.
Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.
Allergy or intolerance to cocoa.
Parallel
Natural Non-Alkalized Cocoa
Dietary supplementStructured 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
BehavioralStructured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
Change in serum sVCAM-1 concentration
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
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
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
Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in \[pg/mL\].
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Change in adherence to the Mediterranean diet measured using the Mediterranean Diet Adherence Screener (MEDAS). Scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.
Incidence of gestational diabetes mellitus
Occurrence of gestational diabetes mellitus diagnosed according to standard clinical criteria and routine screening procedures during pregnancy.
Incidence of gestational hypertension
Occurrence of gestational hypertension diagnosed according to standard clinical criteria during pregnancy.
Incidence of preeclampsia
Occurrence of preeclampsia diagnosed according to standard clinical criteria during pregnancy.
Gestational age at delivery
Gestational age at the time of delivery measured in completed weeks of gestation.
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