UnknownNot Applicable

Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease

Ireland60 participantsStarted 2023-06-01

Plain-language summary

This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).

Who can participate

Age range

18 Years – 65 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: * Males and females * Age 18-65 years, from all ethnic groups, capable of providing informed consent to participate * Obesity (body mass index \>30kg/m\^2) and of stable body weight (±3% for ≥3 months) * Fasting blood glucose \<7.0 mmol/L and HbA1c \<6.5%. * Liver fat \>10% (CAP score \>238 dB/m) and no fibrosis (liver stiffness score 2-7 kPa) as assessed by liver elastography (FibroScan) Exclusion Criteria: * Impaired renal function * Abnormal hematocrit * History of cardiovascular events * Uncontrolled hypertension * Type 2 diabetes * Medications or supplements known to affect glucose or lipid metabolism * Active inflammatory, autoimmune, infectious, gastrointestinal, or malignant disease * Uncontrolled neurological or psychiatric disease * Iron deficiency anemia, (hemoglobin \< 12g/dl men, \< 11g/dl women) * Fatty acid supplements and consumers of high doses of anti- antioxidant vitamins (A, C, E, b-carotene)

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

Change in plasma inflammatory response to a high-fat meal: C-reactive protein (CRP)

Timeframe: To be assessed at baseline and post 8-week intervention

Change in plasma inflammatory response to a high-fat meal: Interleukin-6 (IL-6)

Timeframe: To be assessed at baseline and post 8-week intervention

Change in plasma inflammatory response to a high-fat meal: Interleukin-1-beta (IL-1β)

Timeframe: To be assessed at baseline and post 8-week intervention

Change in plasma inflammatory response to a high-fat meal: Tumor necrosis factor alpha (TNF-α)

Timeframe: To be assessed at baseline and post 8-week intervention

Trial details

NCT IDNCT05968378

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Helen M Roche, Professor

+353017164031 helen.roche@ucd.ie

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials