Effects of Intermittent Fasting on Fatty Liver Disease (NCT04795973) | Clinical Trial Compass
CompletedNot Applicable
Effects of Intermittent Fasting on Fatty Liver Disease
China80 participantsStarted 2020-09-22
Plain-language summary
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* hepatic fat content (HFC) \> 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations
* age ≥ 18 years
* body mass index (BMI) ≥ 18.5 kg/m2
* stable body weight (change \< ± 10% of body weight) during the last 3 months
Exclusion Criteria:
* plasma aspartate aminotransferase (AST) and alanine amino-transferase (ALT) levels exceeded 2.5 times of the upper limit of normal
* fasting blood glucose (FBG) levels ≥ 7.0 mmol/L or glycated hemoglobin A1c (HbA1c) ≥ 6.5%
* with type 1 or type 2 diabetes
* with heart disease
* with other hepatic disease (excluding FLD)
* with renal disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer
Timeframe: 8 weeks
2
TSH Index (TSHI) calculated from serum TSH and FT4 levels
Timeframe: 8 weeks
3
Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels
Timeframe: 8 weeks
4
FT3/FT4 ratio calculated from serum FT3 and FT4 levels
Timeframe: 8 weeks
5
Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays.
Timeframe: 8 weeks
6
Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging