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

N/ANot Yet RecruitingNCT07656532

University of Salamanca60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pregnancy

Interventions

Natural Non-Alkalized CocoaDIETARY_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 CounselingBEHAVIORAL

Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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 \[ng/mL\].

Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation

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.

Time frame: Baseline, 24-28 weeks of gestation, 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 \[pg/mL\].

Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation.

Change in serum IL-6 concentration

Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in \[pg/mL\].

Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation

Secondary Outcomes

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.