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

Launched by UNIVERSITY OF PARMA · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a personalized, plant-based diet that is high in natural compounds called (poly)phenols can improve heart and metabolic health. Researchers want to understand if the benefits of this diet depend on how well each person can process these (poly)phenols, which are found in many fruits, vegetables, and whole grains. The study will involve observing participants to find out more about their health and diet, and then testing how the diet affects their health over time.

To be eligible for this trial, participants should be adults aged 40 to 80 who do not have diagnosed heart or metabolic diseases but have at least one risk factor, such as being overweight, having high blood pressure, or abnormal cholesterol levels. Participants will be expected to follow a specific Mediterranean-style diet and provide information about their health throughout the study. It’s important to note that some people cannot join the trial, including those with certain health conditions, recent surgeries, or difficulties with eating plant-based foods. This trial is currently recruiting participants, and it offers a chance to learn more about how diet can impact individual health.

Gender

ALL

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 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