Endothelial Dysfunction, Gestational Diabetes Mellitus (GDM), Hypertension, Pregnancy-Induced, Oxidative Stress, Preeclampsia, Pregnancy
Conditions
Keywords
Mediterranean diet, Polyphenols, Cocoa supplementation, Oxidative stress, Endothelial function, Randomized controlled trial
Brief 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.
Interventions
DIETARY_SUPPLEMENTNatural 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.
BEHAVIORALPolyphenol-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.
Sponsors
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Biological samples will be analyzed by laboratory staff blinded to group allocation. Samples will be coded prior to analysis to ensure that outcome assessors are unaware of whether participants belong to the intervention or control group. This procedure is intended to minimize measurement bias in biochemical and oxidative stress biomarkers.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving a polyphenol-rich dietary intervention or a control group receiving standard dietary advice. Both groups will be followed in parallel throughout pregnancy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum sVCAM-1 concentration | Baseline, 24-28 weeks, and 32-36 weeks of gestation | Change in serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levels from baseline to 24-28 weeks of gestation, measured in \[ng/mL\]. |
| Change in serum sFlt-1/PlGF ratio | Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation. | 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. |
| Change in serum nitric oxide concentration | Baseline, 24-28 weeks, and 32-36 weeks of gestation. | Change in serum nitric oxide (NO) concentration from baseline to 24-28 weeks and 32-36 weeks of gestation, measured in \[pg/mL\]. |
| Change in serum IL-6 concentration | Baseline, 24-28 weeks, and 32-36 weeks of gestation | Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in \[pg/mL\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mediterranean Diet Adherence Screener (MEDAS) score | Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation. | 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. |
Countries
Spain
Contacts
CONTACTAna García Albarrán, RN, Midwife
CONTACTMaría Begoña Ayuda Durán, PharmD
PRINCIPAL_INVESTIGATORAna García Albarrán, RN, Midwife
University of Salamanca
STUDY_DIRECTORSusana González Manzano, PharmD
University of Salamanca
STUDY_DIRECTORMaría Begoña Ayuda Durán, PharmD
University of Salamanca
Outcome results
None listed