Personalized plant-based diet to improve heart and metabolic health
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)
This study is testing if a personalized plant-based diet high in certain compounds can improve heart and metabolic health in people at risk for these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Parma Academic / other |
| Locations | 2 sites (Parma, PR and 1 other locations) |
| Trial ID | NCT06347094 on ClinicalTrials.gov |
What this trial studies
This study investigates how a personalized diet rich in (poly)phenols affects cardiometabolic health based on individual metabolism of these compounds. It involves recruiting 330 participants at risk for cardiometabolic issues, who will undergo an oral (poly)phenol challenge test to categorize them into different metabotypes. The study includes an observational phase to gather lifestyle data and an experimental phase where participants will be randomly assigned to either increase their (poly)phenol intake or maintain their usual diet. Various health metrics, including blood pressure and metabolic markers, will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-80 who are at risk for cardiometabolic diseases but have not been clinically diagnosed.
Not a fit: Patients with a BMI below 18.5 or above 34.9 kg/m², or those with a history of cardiovascular events or metabolic diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to tailored dietary interventions that significantly improve cardiometabolic health in individuals.
How similar studies have performed: Previous studies have shown promise in personalized dietary interventions for improving health outcomes, but this specific approach focusing on (poly)phenol metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Parma, PR and 1 other locations
- University of Parma - Plesso Biotecnologico Integrato — Parma, Pr, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Pr, Italy (Recruiting)
Study contacts
- Principal investigator: Pedro M Mena Parreño, PhD — University of Parma
- Study coordinator: Pedro M Mena Parreño, PhD
- Email: pedromiguel.menaparreno@unipr.it
- Phone: +39 0521 903970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.