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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04988633
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness \<8 Kpa.
Exclusion Criteria:
* Serious chronic disease (heart, respiratory, cancer, etc.).
* Chronic liver disease.
* Chronic kidney disease (FGR \<60ml/min).
* Weight loss\> 5% during the last three months.
* AUDIT- C\> 8
* Impossibility to follow the recommended diet (for religious reasons, swallowing problems, etc.) or inability to perform physical activity.
* Inability to follow the scheduled visits to the intervention (institutionalized individuals, lack of autonomy, inability to walk, lack of a stable home, travel plans, etc.).
* Have been included in another weight loss advice program (\>5 kg) during the 6 months prior to the selection visit (basal visit).
* History of having followed a low calorie diet (\<900Kcal/day) for the last 6 months.
* History of surgical procedures to lose weight or intend to undergo bariatric surgery in the next 12 months.
* Hemoglobin A1c ≥ 9%.
* History of resection of the small or large intestine.
* History of inflammatory bowel disease.
* BMI\> 40 or obesity of known endocrine origin (with the exception of treated hypothyroidism).
* Current treatment with systemic corticosteroids.
* Current use of medication for weight loss.
* Current treatment with steatogenic drugs.
* People participating in a clinical trial with drugs.
* Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
* Refusal to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04988633
Study Brief:
Protocol Section:
NCT04988633