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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03183193
Eligibility Criteria:
Inclusion Criteria:
* Overweight or obese
* Diagnosis of NAFLD
* Age: 30-80 years
* Female / Male
Exclusion Criteria:
* Known liver disease (other than NAFLD)
* Abuse of alcohol (\>21 and \>14 units of alcohol a week for men and women, respectively, eg 1 unit = 125 mL of wine);
* Drug treatments: immunosuppressants, cytotoxic agents, systemic corticosteroids, agents potentially causing fatty liver disease or abnormal liver tests or weight modifiers
* Active cancer or a history of malignancy in the last 5 years
* Problems of massive edemas
* Obesity known endocrine origin (except treated hypothyroidism)
* Surgical procedure for weight loss
* ≥ 3kg weight loss in the last 3 months
* Severe psychiatric disorders
* Lack of autonomy or inability to follow the diet (including food allergies or intolerances) or/and lifestyle recommendations as well as to follow scheduled visits.
* Consumption of any type of food supplements (antioxidants, prebiotics, probiotics, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03183193
Study Brief:
Protocol Section:
NCT03183193