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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT04415632
Eligibility Criteria:
Inclusion Criteria:
* • Adult males and females aged from 18 to 65 years (balanced number).
* Detected NAFLD by CAP-FibroScan™ \>288dB/m or by MRI-PDFF) \> 5% fat of liver weight.
* Body mass index ≥ 25 kg/m2
* Have current moderate to high GI diet intake of ≥ 60 (Assessed from a completed 7-day food diary).
* Abdominal obesity (Waist circumference \> 102 cm for males and \> 88 cm for females)
* Able to give informed consent.
* Able to undergo MRI/S and CAP-FibroScan™.
Exclusion Criteria:
* • Current smokers and excessive alcohol drinkers (\> 14 units/week).
* Perimenopausal (irregular periods) women.
* Participants with other liver abnormalities.
* Participants with history of gastrointestinal surgeries, depression, eating disorders or difficulties.
* Participants using pharmacologic agents for obesity or NAFLD.
* Participants with type 1 diabetes.
* Participants with type 2 diabetes on second line medications (eg GLP-1 analogues, sulfonylureas).
* Participation in any other trial in the last 3 months.
* Participants on any special diets (e.g. vegetarians).
* Intolerance to foods included in the diet plan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04415632
Study Brief:
Protocol Section:
NCT04415632