Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy (PREGPOLY)
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ana García Albarrán, RN, Midwife
- 전화번호: 923291100
- 이메일: annagarcialbarran@usal.es
연구 연락처 백업
- 이름: María Begoña Ayuda Durán, PharmD
- 전화번호: +34 923 294 537
- 이메일: bego_ayuda@usal.es
연구 장소
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SALAMANCA
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Salamanca, SALAMANCA, 스페인, 37007
- Hospital de Salamanca
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연락하다:
- Ana García Albarrán, RN, Midwife
- 전화번호: 923291100
- 이메일: annagarcialbarran@usal.es
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum sVCAM-1 concentration
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Mediterranean Diet Adherence Screener (MEDAS) score
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of gestational diabetes mellitus
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ana García Albarrán, RN, Midwife, University of Salamanca
- 연구 책임자: Susana González Manzano, PharmD, University of Salamanca
- 연구 책임자: María Begoña Ayuda Durán, PharmD, University of Salamanca
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- USAL-CT-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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