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:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03783195
Eligibility Criteria:
Inclusion Criteria:
1. Subjects 12 - 40 years
2. No history of alcohol abuse (\> 7 drinks per week)
3. History of fructose intake of \< 14 drinks per week
4. Caucasian ethnicity
5. BMI \> 25kg/m² - 32kg/m² or 85th -99th percentile but otherwise healthy
Exclusion Criteria:
1. ages \< 12 and \> 40 years
2. Pregnant/lactating
3. known alcohol abuse or fructose intake \> 14 drinks per week
4. not of Caucasian ethnicity
5. glucose levels \> 100 mg/dL if fasting, \> 140mg/dL if within 2 hours post meal and \> 200 mg/dL if random sample
6. taking anti-hypertensive, anti-diabetic, uric acid and/or lipid-lowering medications
7. known diagnosis of diabetes, fructose intolerance, chronic kidney disease, NAFLD or any liver-related disease, hypertriglyceridemia, polycystic ovary syndrome, hypothyroidism, obstructive sleep apnea, hypopituitarism and hypogonadism
8. BMI \< 25kg/m² or \> 32 kg/m² or \< 85th or \> 99th percentile
9. Liver fat fraction \>5% as per baseline MRI scan
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
40 Years
Study:
NCT03783195
Study Brief:
Protocol Section:
NCT03783195