Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD (NCT05866744) | Clinical Trial Compass
CompletedNot Applicable
Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD
Greece59 participantsStarted 2023-05-08
Plain-language summary
The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.
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:
* Body Mass Index \>25 kg/m2
* Liver steatosis with Magnetic Resonance Elastography (MRE)
Exclusion Criteria:
* Other chronic liver diseases
* Alcohol consumption \>20 g/day (female) and \>30 g/day (male)
* Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
* Changes in body weight ± 3 % in the last 3 months
* Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
* Unstable glucose-lowering medications in the last 6 months
* Body weight lowering medications and/or history of bariatric surgery
* Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
* Uncontrolled type 2 diabetes mellitus defined as HbA1c value \> 9.0% or insulin depending type 1 and 2 diabetes mellitus
* Pregnancy
* Lactation
* Immunologic or inflammatory diseases
* Depression and other psychiatric diseases
* Patients working in shifts
* Cancer
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.