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NCT06705868

Chrononutrition/ Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.

Sponsor: Cyprus University of Technology

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-05

Completion Date

2029-12-15

Last Updated

2025-11-19

Healthy Volunteers

Conditions

MASLD MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease NAFLD NAFLD - Non-Alcoholic Fatty Liver Disease NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

OTHER

Diet-Time-restricted eating (TRE)

Ad libitum time-restricted scheme with a further time-restriction on fruit and vegetable consumption in participants with MASLD

OTHER

Lifestyle Management

The SoC intervention refers to an adaptation of a healthier lifestyle in elements that have to do with weight management, adopting healthier dietary habits, alcohol intake reduction, increase physical activity levels, in people diagnosed with MASLD.

Inclusion Criteria: 1. Body mass index 25 (±0,5)-45(±0,5) kg/m2 2. Clinical diagnosis of MASLD, not excluding undiagnosed NASH or with NASH stage F0-F1 3. Self-reported habitual eating period more than or equal to 14 h per day, BUT NOT LESS. 4. Cyprus inhabitants of for at least 1 year 5. Registered to the National Health System of the Republic of Cyprus (Gesy Exclusion Criteria: 1. Night Shift worker 2. Fasting \>12-h/day more than once a week or \> once a week no food intake after 18:00 3. Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to: 1. Positive hepatitis B surface antigen 2. Positive hepatitis C virus RNA 3. Suspicion of drug-induced liver disease 4. Alcoholic liver disease 5. Autoimmune hepatitis 6. Wilson's disease 7. Hemochromatosis 8. Primary biliary cholangitis or primary sclerosing cholangitis 9. Known or suspected hepatocellular carcinoma 4. 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) 5. 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) 6. Doctor diagnosed diabetes mellitus on insulin or sulfonylureas 7. Severe medical comorbidities \[ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \>200/120 mmHg)\] 8. Unstable weight (\>5% change in the last 2 months) or participation in a weight-loss program within the past 12 weeks 9. Sleep disorder (with a medical diagnosis) or individuals self-reporting sleep difficulties and poor sleep \[average sleep less than 6 consecutive hours or patients who systematically experience sleep interruption for more than 2 times each night (waking up for toilet use is not to be considered sleep interruption)\] 10. Individuals with food allergies (or hypersensitivity to the fruits and vegetables that will be selected for the study) 11. Systematic organic products consumers (defined as a self-reported usual consumption of more than 80% of their weekly fruits \& vegetables being organic) 12. Pregnant or trying to become pregnant or lactating women 13. People not in position to communicate in Greek or English language 14. Having metallic parts in the body.

Locations (1)

Limassol General Hospital

Limassol, Cyprus