Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy (NCT07656532) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy
Spain60 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at markers like the sFlt-1/PlGF ratio and sVCAM-1, which are linked to preeclampsia risk — given my personal pregnancy history or risk factors, does it make sense for me to have these markers monitored, whether or not I join this trial?
2Since this trial isn't recruiting yet, what are my options right now if I'm concerned about oxidative stress or endothelial dysfunction during my pregnancy — are there evidence-based dietary approaches, like a Mediterranean diet, that you'd already recommend while I wait to see if this study opens?
3The trial is categorized as 'Phase NA,' which suggests it's more of an observational or dietary study than a drug trial — can you help me understand what that means for what I'd actually be asked to do, and whether there are any risks involved in changing my diet or having extra blood draws during pregnancy?
4If I have risk factors for gestational diabetes or preeclampsia, would participating in a study focused on polyphenol intake and diet actually be a good fit for my care plan, or is there a more established treatment path you'd recommend I prioritize first?
5Because this trial is measuring inflammation markers like IL-6 and nitric oxide alongside diet, what would the results actually tell us — and how might that information be useful for managing my pregnancy health even if the study isn't completed before I deliver?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum sVCAM-1 concentration
Timeframe: Baseline, 24-28 weeks, and 32-36 weeks of gestation
2
Change in serum sFlt-1/PlGF ratio
Timeframe: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
3
Change in serum nitric oxide concentration
Timeframe: Baseline, 24-28 weeks, and 32-36 weeks of gestation.
4
Change in serum IL-6 concentration
Timeframe: Baseline, 24-28 weeks, and 32-36 weeks of gestation