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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT04442620
Eligibility Criteria:
Inclusion Criteria:
* Age between 40 and 60 years
* Diagnosis of NAFLD by ultrasound
* BMI ≥ 27 and \< 40 kg/m2
* Meeting at least 3 of 5 criteria for the metabolic syndrome \[as described in the International Diabetes Federation consensus\]: (1) BMI \>30kg/m² or increased waist circumference: ≥ 94 cm in males; ≥ 80 cm in females; (2) Triglycerides (TG) levels ≥ 150 mg/dL (1.7 mmol/L) or specific treatment; (3) Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in males; \< 50 mg/dL (1.29 mmol/L) in females or specific treatment; (4) Raised blood pressure: systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension; (5) Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
* Written informed consent
Exclusion Criteria:
* Inability or unwillingness to give informed consent or communicate with staff study
* Documented history of prior cardiovascular disease \[angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or hemorrhagic including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class III or IV); hypertrophic myocardiopathy; and history of aortic aneurism \>=5.5cm in diameter or aortic aneurism surgery\]
* Documented history of prior liver diseases (other than NAFLD)
* Active cancer or a history of malignancy in the last 5 years
* Low predicted probability to change food habits according to the Stages of Change Model (Nigg, 1999)
* Unwillingness or inability to adhere to the dietary and physical activity intervention over the entire period of the study
* Failure to follow scheduled visits
* Weight loss (\>5 kg) during 6 months prior to visit
* Previous surgical procedures for weight loss or scheduled bariatric surgery within the next 12 months
* Use of weight loss medications during 6 months prior to visit
* Previous history of bowel resection, inflammatory bowel disease
* Obesity associated with endocrine disease (except treated hypothyroidism)
* Allergy to Mediterranean diet foods or components
* Severe psychiatric disorders (schizophrenia, bipolar disorder, eating disorders, or depression with hospitalization within the last 6 months) or Beck Depression Inventory score \> 30
* Severe condition with less than 24 months life expectancy
* Chronic abuse of drugs or alcohol (\>21 and \>14 units of alcohol a week for men and women, respectively; 1 unit = 125 mL of wine)
* Treatment with steroids
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT04442620
Study Brief:
Protocol Section:
NCT04442620