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

Sponsor
University of Salamanca
Study ID
NCT07656532
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

First listed
Jun 18, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Participants will receive a daily dietary intervention consisting of 10 g of natural non-alkalized cocoa and structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables, in addition to general Mediterranean diet recommendations. The intervention will last 12 weeks during pregnancy.
  • Active Comparator: Control Group
    Participants will receive standard dietary advice based on general healthy eating and Mediterranean diet recommendations during pregnancy, without specific supplementation or structured dietary intervention.

Primary Outcome Measure

Change in serum sVCAM-1 concentration [ Time Frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation ]

Central Contacts

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