Clinical Trial

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

Study acronym: PREGPOLY
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07656532
Lead Sponsor University of Salamanca
Conditions Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia, Hypertension, Pregnancy-Induced, Oxidative Stress, Endothelial Dysfunction
Enrollment 60 participants
Start Date 2026-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-18