Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06347094
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06347094
Study Brief:
Protocol Section:
NCT06347094