Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT06705868
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06705868
Study Brief:
Protocol Section:
NCT06705868