[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641377":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":48,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Salamanca","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","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.",[13,14],"Dietary Supplement: Natural Non-Alkalized Cocoa","Behavioral: Polyphenol-Rich Dietary Counseling",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Participants will receive standard dietary advice based on general healthy eating and Mediterranean diet recommendations during pregnancy, without specific supplementation or structured dietary intervention.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","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.",[9],null,{"type":28,"name":29,"description":24,"armGroupLabels":30,"otherNames":26},"BEHAVIORAL","Polyphenol-Rich Dietary Counseling",[16,9],[32,35,38],{"name":33,"affiliation":5,"role":34},"Ana García Albarrán, RN, Midwife","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Susana González Manzano, PharmD","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":37},"María Begoña Ayuda Durán, PharmD",[41,45],{"name":33,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","923291100","annagarcialbarran@usal.es",{"name":39,"role":42,"phone":46,"phoneExt":26,"email":47},"+34 923 294 537","bego_ayuda@usal.es",[49],{"facility":50,"status":26,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital de Salamanca","Salamanca","SALAMANCA","37007","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-5.66388,40.96882,{"lat":60,"lon":59},[63],{"name":33,"role":42,"phone":43,"phoneExt":26,"email":44},{"type":34,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ana García Albarrán","PI-PhD-Nurse and Midwife","100641377","polyphenol-intake-mediterranean-diet-adherence-and-oxidative-stress-in-pregnancy-100641377",false,"NCT07656532","Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy","Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy","PREGPOLY","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older.\n* Singleton pregnancy.\n* Gestational age between 8 and 11 weeks at enrollment.\n* Receiving prenatal care within the Salamanca Health Area.\n* Able to understand the study information and provide written informed consent.\n* No clinical restrictions that would contraindicate dietary modifications.\n\nExclusion Criteria:\n\n* Medical or obstetric conditions that contraindicate dietary modifications.\n* Active metabolic, renal, or hepatic disease.\n* Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.\n* Allergy or intolerance to cocoa.\n* Habitual high cocoa or chocolate consumption (\\>30 g\u002Fday).\n* Multiple pregnancy.\n* Severe obstetric complications diagnosed before enrollment.\n* Inability to comply with study procedures, attend follow-up visits, or communication barriers that could interfere with participation.",true,"FEMALE","18 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nPregnancy 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.\n\nPregnant 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.\n\nThe 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.\n\nThe aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.",[86,87,88,89,90,91],"Pregnancy","Gestational Diabetes Mellitus (GDM)","Preeclampsia","Hypertension, Pregnancy-Induced","Oxidative Stress","Endothelial Dysfunction",[93,94,95,96,97,98],"Mediterranean diet","Polyphenols","Cocoa supplementation","Oxidative stress","Endothelial function","Randomized controlled trial","NOT_YET_RECRUITING","2026-06-14",{"date":102,"type":103},"2026-06-18","ACTUAL",{"date":105,"type":80},"2026-09-01",{"date":107,"type":80},"2028-10-01",{"name":5,"class":6},1]