Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)
University of Parma
330 participants
Apr 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria15
- BMI < 18.5 or > 34.9 kg/m²
- Past cardiovascular events and metabolic diseases including diabetes
- Inflammatory bowel diseases or gastro-intestinal surgery (other than appendectomy)
- Cholecystectomy within the past 5 years
- Renal or hepatic diseases
- Levels of estimated Glomerular Filtration (eGFR) < 60 mL/min/1.73 m²
- Aspartate transaminase (AST)/alanine aminotransferase (ALT) 2.5 times the upper limits of normal
- Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)
- Mental disorders
- Hormone therapy (other than that used for hypothyroidism, birth-control or menopause symptoms)
- Antibiotic therapy within the last month before the study
- Food allergies associated with the consumption of plant foods or foods that will be provided in the study
- Difficulties or major inconveniences in changing dietary habits or adhering to a plant-based Mediterranean-type diet
- Presence of chewing or swallowing disorders
- Pregnancy or lactation
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Interventions
Prescription of dietary plans increasing the intake of (poly)phenols through consumption of foods rich in these compounds, in the context of a balanced, personalised diet
Nutritional challenge with standardized (poly)phenol-rich tablets
Prescription of balanced dietary plans
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06347094