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NCT Number: NCT07656532

Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in 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.

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Key information

Conditions

Pregnancy Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Endothelial Dysfunction Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus (GDM) Glucose Metabolism Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Salamanca

Salamanca, SALAMANCA, 37007, Spain

Location contact

Ana García Albarrán, RN, Midwife

CONTACT

[email protected]

923291100

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natural Non-Alkalized Cocoa

Dietary Supplement

Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.

Polyphenol-Rich Dietary Counseling

Behavioral

Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.

Primary outcomes

  1. Change in serum sVCAM-1 concentration

    Time frame: 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].

  2. Change in serum sFlt-1/PlGF ratio

    Time frame: 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.

  3. Change in serum nitric oxide concentration

    Time frame: 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].

  4. Change in serum IL-6 concentration

    Time frame: 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 outcomes

  1. Change in Mediterranean Diet Adherence Screener (MEDAS) score

    Time frame: 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.

Other outcomes

  1. Incidence of gestational diabetes mellitus

    Time frame: 24-28 weeks of gestation.

    Occurrence of gestational diabetes mellitus diagnosed according to standard clinical criteria and routine screening procedures during pregnancy.

  2. Incidence of gestational hypertension

    Time frame: From enrollment until delivery.

    Occurrence of gestational hypertension diagnosed according to standard clinical criteria during pregnancy.

  3. Incidence of preeclampsia

    Time frame: From enrollment until delivery.

    Occurrence of preeclampsia diagnosed according to standard clinical criteria during pregnancy.

  4. Gestational age at delivery

    Time frame: At delivery.

    Gestational age at the time of delivery measured in completed weeks of gestation.

  5. Neonatal birth weight

    Time frame: At delivery.

    Neonatal birth weight measured in grams.

  6. Apgar score at 1 minute

    Time frame: 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.

  7. Apgar score at 5 minutes

    Time frame: 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.

  8. Apgar score at 10 minutes

    Time frame: 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.

  9. Neonatal intensive care unit admission

    Time frame: At delivery

    Proportion of newborns requiring admission to the neonatal intensive care unit (NICU).

Study contacts

Contact information is provided by the study sponsor or research team.

Ana García Albarrán, RN, Midwife

CONTACT

[email protected]

923291100

María Begoña Ayuda Durán, PharmD

CONTACT

[email protected]

+34 923 294 537

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy

Acronym: PREGPOLY

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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