protocolSection identificationModule nctId: NCT06347094, orgStudyIdInfo id: 610/2023/SPER/UNIPR, briefTitle: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols, acronym: PRE-CARE-DIET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Parma, class: OTHER, collaborators name: Azienda Ospedaliero-Universitaria di Parma, collaborators name: University of Milan, collaborators name: Foundation for Liver Research, collaborators name: National Research Council, Spain, descriptionModule briefSummary: This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping., conditionsModule conditions: Individual Variability in (Poly)Phenol Metabolism, conditions: Cardiometabolic Health, conditions: Personalized Dietary Intervention, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Metabotypes will also be masked to participants and investigators, while the dietary treatment will not., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Dietary Plan, interventions name: Oral (Poly)phenol Challenge Test (OPCT), interventions name: General Dietary Advice, outcomesModule primaryOutcomes measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation, primaryOutcomes measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons, secondaryOutcomes measure: Anthropometric measurements: weight, height and body mass index, secondaryOutcomes measure: Anthropometric measurements: waist and hip circumferences detection, secondaryOutcomes measure: Body composition: bioelectrical impedance analysis, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Biomarkers of cardiometabolic health: hematochemical and urine analysis, secondaryOutcomes measure: Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homocysteine, secondaryOutcomes measure: Biomarkers of cardiometabolic health: insulin, secondaryOutcomes measure: Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin, secondaryOutcomes measure: Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance, secondaryOutcomes measure: Inflammatory status, secondaryOutcomes measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years, secondaryOutcomes measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years, secondaryOutcomes measure: Risk prediction scores: Hard Coronary Heart Disease - 10-years risk, secondaryOutcomes measure: Risk prediction scores: First Coronary Heart Disease - 2-years risk, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Diabetes, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Hypertension, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Stroke, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Fatty Liver Disease, secondaryOutcomes measure: Risk prediction scores: Atherosclerotic Cardiovascular Disease, secondaryOutcomes measure: Risk prediction scores: QRESEARCH risk estimator version 3, secondaryOutcomes measure: Risk prediction scores: QDiabetes Score, secondaryOutcomes measure: Risk prediction scores: Finnish Diabetes Risk Score, secondaryOutcomes measure: Risk prediction scores: Cuore Project - Calculating the individual risk score, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: DASH Index, secondaryOutcomes measure: Evaluation of adherence to Mediterranean diet, secondaryOutcomes measure: Nutritional and energy assessment: LARN, secondaryOutcomes measure: Nutritional and energy assessment: EPIC, secondaryOutcomes measure: Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome, secondaryOutcomes measure: Lifestyle factors assessment: general information, secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (PSQI), secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (ESS), secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (ISI), secondaryOutcomes measure: Lifestyle factors assessment: physical activity (IPAQ), secondaryOutcomes measure: Lifestyle factors assessment: state of health (BDI), secondaryOutcomes measure: Lifestyle factors assessment: state of health (SF-36), secondaryOutcomes measure: (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes, secondaryOutcomes measure: Other plant bioactive metabolites, secondaryOutcomes measure: Food/gut/host-derived metabolites, secondaryOutcomes measure: Biomarkers of food intake and of healthy dietary patterns, secondaryOutcomes measure: Untargeted metabolomics, secondaryOutcomes measure: Genetic differences, secondaryOutcomes measure: Gut microbiota composition, secondaryOutcomes measure: Oral microbiota composition, secondaryOutcomes measure: Biomarkers of adipose tissue function, secondaryOutcomes measure: Biomarkers of food intake regulation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Parma - Plesso Biotecnologico Integrato, city: Parma, state: PR, zip: 43125, country: Italy, contacts name: Pedro M Mena Parreño, PhD, role: CONTACT, phone: +39 0521 903970, email: pedromiguel.menaparreno@unipr.it, contacts name: Joana M Santos Rebelo, MSc, role: CONTACT, phone: +39 0521902043, email: joanamaria.santosrebelo@unipr.it, contacts name: Pedro M Mena Parreño, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Azienda Ospedaliero-Universitaria di Parma, city: Parma, state: PR, zip: 43126, country: Italy, contacts name: Riccardo Bonadonna, MD, role: CONTACT, phone: +39 0521 033307, email: riccardo.bonadonna@unipr.it, geoPoint lat: 44.79935, lon: 10.32618, hasResults: False