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

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Salamanca

  lead OTHER

Principal Investigators

• Ana García Albarrán, RN, Midwife · University of Salamanca

• Susana González Manzano, PharmD · University of Salamanca

• María Begoña Ayuda Durán, PharmD · University of Salamanca

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-09-01

Completion

2028-10-01

Countries

• Spain

Study Locations