Tests time-restricted eating in adults with fatty liver disease

Trial details

Who runs it

Cyprus University of Technology

Trial code

NCT06705868

Record updated

19 November 2025

Original description

The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).Read full original descriptionShow less

Time-restricted Eating in Patients With Metabolic-associated Steatotic Liver Disease . CHRONOMASLD: A Chrononutrition/Chronotoxicity Randomized Controlled Trial.

The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).

The protocol of the study is an intention to treat protocol. The main research questions are:

1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD? 2. Does an additional time restriction on the consumption of fruits and vegetables within the "light-window" of the day affects the metabolism of food contaminants?

Participants will be asked to:

1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time. 2. Adhere to a further time restricted consumption of a "5-a-day" portions of fruits and vegetables between the "light-window hours" between 9am to 4pm. 3. Visit the Nutrition \& Dietetics Clinic once every month for anthropometric measurements (on 4 time points). 4. Collect and deliver first morning urine samples (on 7 time points). 5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)

5) Complete a compliance and lifestyle questionnaire questionnaire via telephone interview to the research team every 2 weeks.

6) Share photos to the research team with the use of an application on time of actual fruit and vegetables consumption, 3-4 times per week throughout the study protocol.

Researchers will compare the designed intervention package of this TRE with the Standard of Care (SoC) protocol (based on the international guidelines) that is currently used in daily practice for the management of MASLD.

Inclusion: Body mass index 25 (±0,5)-45(±0,5) kg/m2; Clinical diagnosis of MASLD, not excluding undiagnosed NASH or with NASH stage F0-F1; Self-reported habitual eating period more than or equal to 14 h per day, BUT NOT LESS; Cyprus inhabitants of for at least 1 year; Registered to the National Health System of the Republic of Cyprus (Gesy.

Exclusion: Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:; Positive hepatitis B surface antigen; Positive hepatitis C virus RNA; Suspicion of drug-induced liver disease; Alcoholic liver disease; Autoimmune hepatitis; Wilson's disease; Hemochromatosis; Primary biliary cholangitis or primary sclerosing cholangitis; Known or suspected hepatocellular carcinoma; Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks); Doctor diagnosed diabetes mellitus on insulin or sulfonylureas; Severe medical comorbidities [ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure >200/120 mmHg)]; Sleep disorder (with a medical diagnosis) or individuals self-reporting sleep difficulties and poor sleep [average sleep less than 6 consecutive hours or patients who systematically experience sleep interruption for more than 2 times each night (waking up for toilet use is not to be considered sleep interruption)]; Individuals with food allergies (or hypersensitivity to the fruits and vegetables that will be selected for the study); Current or recent history (<5 years) of significant alcohol intake (>30g of alcohol/ day or >210g/week for men, >20g of alcohol/day or >140g/week for women); Night Shift worker; Fasting >12-h/day more than once a week or > once a week no food intake after 18:00; Unstable weight (>5% change in the last 2 months) or participation in a weight-loss program within the past 12 weeks; Systematic organic products consumers (defined as a self-reported usual consumption of more than 80% of their weekly fruits \& vegetables being organic); Pregnant or trying to become pregnant or lactating women; People not in position to communicate in Greek or English language; Having metallic parts in the body.

ClinicalTrials.gov NCT06705868