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Recruiting NCT06347094

Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols

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Trial Parameters

Condition Individual Variability in (Poly)Phenol Metabolism
Sponsor University of Parma
Study Type INTERVENTIONAL
Phase N/A
Enrollment 330
Sex ALL
Min Age 40 Years
Max Age 80 Years
Start Date 2024-04-22
Completion 2025-12-31
Interventions
Personalized Dietary PlanOral (Poly)phenol Challenge Test (OPCT)General Dietary Advice

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adults (40-80 y.o.) * Non-clinically diagnosed for cardiometabolic diseases at baseline examination * At least one of the following risk factors: overweight or obese, central obesity (waist:hip ratio \> 0.90 in males and \> 0.85 in females or waist circumference ≥ 94 cm in males and ≥ 80 cm in females), hypertension (systolic BP \> 130 or diastolic BP \> 85 mm Hg), low high-density lipoprotein cholesterol levels (\< 40 mg/dL (1.03 mmol/L) in males, \< 50 mg/dL (1.29 mmol/L) in females), or elevated total cholesterol (≥ 200 mg/dL), low-density lipoprotein cholesterol (≥ 130 mg/dL (4.1 mmol/L)), triglyceride (\> 150 mg/dL (1.7 mmol/L)), fasting glucose (\> 100 mg/dL (5.6 mmol/L)) levels, or microalbuminuria (urinary albumin excretion ratio ≥ 20 μg/min or albumin:creatinine ratio ≥ 30 mg/g). Exclusion Criteria: * BMI \< 18.5 or \> 34.9 kg/m² * Past cardiovascular events and metabolic diseases including diabetes * Inflammatory bowel diseases or gastro-intestinal surge

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