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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ana García Albarrán, RN, Midwife
- 電話番号：923291100
- メール：annagarcialbarran@usal.es
研究連絡先のバックアップ
- 名前：María Begoña Ayuda Durán, PharmD
- 電話番号：+34 923 294 537
- メール：bego_ayuda@usal.es
研究場所
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SALAMANCA
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Salamanca、SALAMANCA、スペイン、37007
- Hospital de Salamanca
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コンタクト：
- Ana García Albarrán, RN, Midwife
- 電話番号：923291100
- メール：annagarcialbarran@usal.es
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in serum sVCAM-1 concentration
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Mediterranean Diet Adherence Screener (MEDAS) score
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of gestational diabetes mellitus
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ana García Albarrán, RN, Midwife、University of Salamanca
- スタディディレクター：Susana González Manzano, PharmD、University of Salamanca
- スタディディレクター：María Begoña Ayuda Durán, PharmD、University of Salamanca
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- USAL-CT-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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