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

14. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: María Begoña Ayuda Durán, PharmD
  • Telefonnummer: +34 923 294 537
  • E-post: bego_ayuda@usal.es

Studiesteder

  • Spania
    • SALAMANCA
      • Salamanca, SALAMANCA, Spania, 37007
        • Hospital de Salamanca
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in serum sVCAM-1 concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Tidsramme: 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.

Andre resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Salamanca

Etterforskere

  • Hovedetterforsker: Ana García Albarrán, RN, Midwife, University of Salamanca
  • Studieleder: Susana González Manzano, PharmD, University of Salamanca
  • Studieleder: María Begoña Ayuda Durán, PharmD, University of Salamanca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. oktober 2028

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • USAL-CT-2026-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

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