NCT07656532Not yet recruiting
Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy
Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of Salamanca
- Diseases
- High blood pressure
- NCT number
- NCT07656532
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.