An interventional study of Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet and Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet in Non-Alcoholic Fatty Liver Disease, sponsored by Agricultural University of Athens. Completed at 2 sites in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Agricultural University of Athens · Not applicable, Interventional, and Treatment
The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.
The goal of this clinical trial is to evaluate the effects of the time in which food intake is restricted (morning or evening hours or no restriction in time) on glucose metabolism and liver steatosis in the context of a hypocaloric diet plan in 54 patients with non-alcoholic fatty liver disease (NAFLD). The participants will be divided into 3 groups of 18 individuals each and will be randomly assigned to one of the 3 dietary interventions. In the first group (control group), participants will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week) with the instruction to consume their meals throughout the day, without time restriction. In the second group (early eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 07:00-09:00 and 17:00-19:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. In the third group (late eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 11:00-13:00 and 21:00-23:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 59 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Agricultural University of Athens is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Hypocaloric Mediterranean diet without time restriction in feeding
Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
18 patients with NAFLD will be asked to follow an early 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 08:00-18:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
18 patients with NAFLD will be asked to follow a late 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 12:00-22:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
18 patients with NAFLD will be asked to follow an individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) without time restriction in feeding (eating throughout the day) for 12 weeks
Change in blood glucose concentrations
Clinically significant change in blood glucose concentrations (mg/dL)
Time frame: 12 weeks
Change in body weight
Clinically significant change in body weight (kg)
Time frame: 12 weeks
Change in blood insulin concentrations
Clinically significant change in blood insulin concentrations (μU/L)
Time frame: 12 weeks
Change in Controlled Attenuation Parameter (CAP)
Clinically significant change in CAP (dB/m)
Time frame: 12 weeks
Change in blood lipids levels
Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)
Time frame: 12 weeks
Change in Chronic Liver Disease Questionnaire (CLDQ)
Clinically significant change in health status within individuals with NAFLD. The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7 (minimum frequency of symptoms). The total score is calculated as the average score of the 29 items.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Agricultural University of Athens