Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy (PREGPOLY)
14 juin 2026 mis à jour par: Ana García Albarrán, University of Salamanca
Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ana García Albarrán, RN, Midwife
- Numéro de téléphone: 923291100
- E-mail: annagarcialbarran@usal.es
Sauvegarde des contacts de l'étude
- Nom: María Begoña Ayuda Durán, PharmD
- Numéro de téléphone: +34 923 294 537
- E-mail: bego_ayuda@usal.es
Lieux d'étude
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SALAMANCA
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Salamanca, SALAMANCA, Espagne, 37007
- Hospital de Salamanca
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Contact:
- Ana García Albarrán, RN, Midwife
- Numéro de téléphone: 923291100
- E-mail: annagarcialbarran@usal.es
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention Group
Participants will receive a daily dietary intervention consisting of 10 g of natural non-alkalized cocoa and structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables, in addition to general Mediterranean diet recommendations.
The intervention will last 12 weeks during pregnancy.
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Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
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Comparateur actif: Control Group
Participants will receive standard dietary advice based on general healthy eating and Mediterranean diet recommendations during pregnancy, without specific supplementation or structured dietary intervention.
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Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in serum sVCAM-1 concentration
Délai: Baseline, 24-28 weeks, and 32-36 weeks of gestation
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Change in serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levels from baseline to 24-28 weeks of gestation, measured in [ng/mL].
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Baseline, 24-28 weeks, and 32-36 weeks of gestation
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Change in serum sFlt-1/PlGF ratio
Délai: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
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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.
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Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
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Change in serum nitric oxide concentration
Délai: Baseline, 24-28 weeks, and 32-36 weeks of gestation.
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Change in serum nitric oxide (NO) concentration from baseline to 24-28 weeks and 32-36 weeks of gestation, measured in [pg/mL].
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Baseline, 24-28 weeks, and 32-36 weeks of gestation.
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Change in serum IL-6 concentration
Délai: Baseline, 24-28 weeks, and 32-36 weeks of gestation
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Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in [pg/mL].
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Baseline, 24-28 weeks, and 32-36 weeks of gestation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Mediterranean Diet Adherence Screener (MEDAS) score
Délai: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
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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.
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Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of gestational diabetes mellitus
Délai: 24-28 weeks of gestation.
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Occurrence of gestational diabetes mellitus diagnosed according to standard clinical criteria and routine screening procedures during pregnancy.
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24-28 weeks of gestation.
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Incidence of gestational hypertension
Délai: From enrollment until delivery.
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Occurrence of gestational hypertension diagnosed according to standard clinical criteria during pregnancy.
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From enrollment until delivery.
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Incidence of preeclampsia
Délai: From enrollment until delivery.
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Occurrence of preeclampsia diagnosed according to standard clinical criteria during pregnancy.
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From enrollment until delivery.
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Gestational age at delivery
Délai: At delivery.
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Gestational age at the time of delivery measured in completed weeks of gestation.
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At delivery.
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Neonatal birth weight
Délai: At delivery.
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Neonatal birth weight measured in grams.
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At delivery.
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Apgar score at 1 minute
Délai: At delivery.
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Neonatal condition assessed using the Apgar score at 1 minute after birth.
Scores range from 0 to 10, with higher scores indicating better neonatal condition.
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At delivery.
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Apgar score at 5 minutes
Délai: At delivery.
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Neonatal condition assessed using the Apgar score at 5 minutes after birth.
Scores range from 0 to 10, with higher scores indicating better neonatal condition.
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At delivery.
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Apgar score at 10 minutes
Délai: At delivery.
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Neonatal condition assessed using the Apgar score at 10 minutes after birth.
Scores range from 0 to 10, with higher scores indicating better neonatal condition.
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At delivery.
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Neonatal intensive care unit admission
Délai: At delivery
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Proportion of newborns requiring admission to the neonatal intensive care unit (NICU).
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At delivery
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ana García Albarrán, RN, Midwife, University of Salamanca
- Directeur d'études: Susana González Manzano, PharmD, University of Salamanca
- Directeur d'études: María Begoña Ayuda Durán, PharmD, University of Salamanca
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 septembre 2027
Achèvement de l'étude (Estimé)
1 octobre 2028
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
14 juin 2026
Première publication (Réel)
18 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Maladies vasculaires
- Maladies cardiovasculaires
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Complications de grossesse
- Troubles du métabolisme du glucose
- Diabète sucré
- Hypertension
- Maladies nutritionnelles et métaboliques
- Diabète gestationnel
- Pré-éclampsie
- Hypertension induite par la grossesse
Autres numéros d'identification d'étude
- USAL-CT-2026-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
At present, there is no finalized plan for sharing individual participant data (IPD). Due to the sensitive nature of maternal and neonatal health data and the presence of biological and clinical information, data sharing will be considered in accordance with institutional ethics requirements, participant consent, and applicable data protection regulations.
Any potential future sharing of de-identified data will be determined after study completion and in line with publication and regulatory requirements.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .