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Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy (PREGPOLY)

14 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: María Begoña Ayuda Durán, PharmD
  • Número de teléfono: +34 923 294 537
  • Correo electrónico: bego_ayuda@usal.es

Ubicaciones de estudio

  • España
    • SALAMANCA
      • Salamanca, SALAMANCA, España, 37007
        • Hospital de Salamanca
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Suplemento dietético: 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.
Conductual: 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.
Comparador activo: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in serum sVCAM-1 concentration
Periodo de tiempo: 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].
Baseline, 24-28 weeks, and 32-36 weeks of gestation
Change in serum sFlt-1/PlGF ratio
Periodo de tiempo: 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.
Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
Change in serum nitric oxide concentration
Periodo de tiempo: 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].
Baseline, 24-28 weeks, and 32-36 weeks of gestation.
Change in serum IL-6 concentration
Periodo de tiempo: 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].
Baseline, 24-28 weeks, and 32-36 weeks of gestation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Periodo de tiempo: 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.
Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of gestational diabetes mellitus
Periodo de tiempo: 24-28 weeks of gestation.
Occurrence of gestational diabetes mellitus diagnosed according to standard clinical criteria and routine screening procedures during pregnancy.
24-28 weeks of gestation.
Incidence of gestational hypertension
Periodo de tiempo: From enrollment until delivery.
Occurrence of gestational hypertension diagnosed according to standard clinical criteria during pregnancy.
From enrollment until delivery.
Incidence of preeclampsia
Periodo de tiempo: From enrollment until delivery.
Occurrence of preeclampsia diagnosed according to standard clinical criteria during pregnancy.
From enrollment until delivery.
Gestational age at delivery
Periodo de tiempo: At delivery.
Gestational age at the time of delivery measured in completed weeks of gestation.
At delivery.
Neonatal birth weight
Periodo de tiempo: At delivery.
Neonatal birth weight measured in grams.
At delivery.
Apgar score at 1 minute
Periodo de tiempo: At delivery.
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.
At delivery.
Apgar score at 5 minutes
Periodo de tiempo: At delivery.
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.
At delivery.
Apgar score at 10 minutes
Periodo de tiempo: At delivery.
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.
At delivery.
Neonatal intensive care unit admission
Periodo de tiempo: At delivery
Proportion of newborns requiring admission to the neonatal intensive care unit (NICU).
At delivery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Salamanca

Investigadores

  • Investigador principal: Ana García Albarrán, RN, Midwife, University of Salamanca
  • Director de estudio: Susana González Manzano, PharmD, University of Salamanca
  • Director de estudio: María Begoña Ayuda Durán, PharmD, University of Salamanca

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • USAL-CT-2026-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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