Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Natural Non-Alkalized Cocoa, Polyphenol-Rich Dietary Counseling.
- Who it may be relevant to
- Registry conditions: Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia, Hypertension, Pregnancy-Induced. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy
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.
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.
Primary outcome measures
- Change in serum sVCAM-1 concentration [Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation]
- Change in serum sFlt-1/PlGF ratio [Time frame: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.]
- Change in serum nitric oxide concentration [Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation.]
- Change in serum IL-6 concentration [Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation]
Secondary outcome measures (1)
- Change in Mediterranean Diet Adherence Screener (MEDAS) score [Time frame: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Hospital de Salamanca — Salamanca
Identifiers
NCT: NCT07656532 · USAL-CT-2026-001