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

14 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: María Begoña Ayuda Durán, PharmD
  • Telefoonnummer: +34 923 294 537
  • E-mail: bego_ayuda@usal.es

Studie Locaties

  • Spanje
    • SALAMANCA
      • Salamanca, SALAMANCA, Spanje, 37007
        • Hospital de Salamanca
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Voedingssupplement: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in serum sVCAM-1 concentration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of gestational diabetes mellitus
Tijdsspanne: 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
Tijdsspanne: From enrollment until delivery.
Occurrence of gestational hypertension diagnosed according to standard clinical criteria during pregnancy.
From enrollment until delivery.
Incidence of preeclampsia
Tijdsspanne: From enrollment until delivery.
Occurrence of preeclampsia diagnosed according to standard clinical criteria during pregnancy.
From enrollment until delivery.
Gestational age at delivery
Tijdsspanne: At delivery.
Gestational age at the time of delivery measured in completed weeks of gestation.
At delivery.
Neonatal birth weight
Tijdsspanne: At delivery.
Neonatal birth weight measured in grams.
At delivery.
Apgar score at 1 minute
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At delivery
Proportion of newborns requiring admission to the neonatal intensive care unit (NICU).
At delivery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Salamanca

Onderzoekers

  • Hoofdonderzoeker: Ana García Albarrán, RN, Midwife, University of Salamanca
  • Studie directeur: Susana González Manzano, PharmD, University of Salamanca
  • Studie directeur: María Begoña Ayuda Durán, PharmD, University of Salamanca

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • USAL-CT-2026-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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