About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Night Shift worker
Fasting >12-h/day more than once a week or > once a week no food intake after 18:00
Positive hepatitis B surface antigen
Positive hepatitis C virus RNA
Trial design
Treatments tested in this trial
- Diet-Time-restricted eating (TRE)
- Lifestyle Management
Treatment groups
Sponsors and collaborators
Cyprus University of Technology
Lead sponsor
Cyprus State Heath Organization Services
Collaborator