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

Launched by CYPRUS UNIVERSITY OF TECHNOLOGY · Nov 23, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to investigate how a specific eating pattern called time-restricted eating (TRE) can help people with metabolic dysfunction-associated steatotic liver disease (MASLD). The researchers want to see if following a TRE diet—where participants eat during an 8-hour window each day and fast for the remaining 16 hours—can lead to improvements in body weight and fat. Additionally, they will examine whether limiting the times when participants eat fruits and vegetables affects how well their bodies process certain food contaminants.

To be eligible for this study, participants should be between 25 and 45 kg/m² in body mass index (BMI), have a clinical diagnosis of MASLD, and typically eat for 14 hours or more each day. Participants will follow the TRE diet for three months, visit the clinic monthly for measurements, provide urine and saliva samples at various times, and complete questionnaires every two weeks. Importantly, this trial is not yet recruiting participants, and it is only open to residents of Cyprus who meet the specific criteria.

Gender

ALL

Eligibility criteria

• 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.