Personalized plant-based diet to improve heart and metabolic health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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). In addition, it is necessary that the weight has been stable for at least 3 months. Similarly, concerning an ongoing therapy with medication or supplements, these must have been in use for at least 3 months.

Exclusion Criteria:

* BMI \< 18.5 or \> 40.0 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.