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

Starting soon · Not applicable

Conditions studied: Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia, Hypertension, Pregnancy-Induced, Oxidative Stress, Endothelial Dysfunction

In brief

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.

Key facts

Study ID

NCT07656532

Run by

University of Salamanca

People needed

60

Starts

2026-09-01

Expected to finish

2028-10-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Able to understand the study information and provide written informed consent.
• No clinical restrictions that would contraindicate dietary modifications.

You may not qualify if…

• 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.
• Habitual high cocoa or chocolate consumption (>30 g/day).
• Multiple pregnancy.
• Severe obstetric complications diagnosed before enrollment.
• Inability to comply with study procedures, attend follow-up visits, or communication barriers that could interfere with participation.

Where it is running

• Hospital de Salamanca — Salamanca, SALAMANCA, Spain

Full record on ClinicalTrials.gov

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