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