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| Name | Class |
|---|---|
| Laikο General Hospital, Athens | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet |
|
| Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet |
|
| Hypocaloric Mediterranean Diet Without Time Restriction In Feeding | Active Comparator | Hypocaloric Mediterranean diet without time restriction in feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose concentrations | Clinically significant change in blood glucose concentrations (mg/dL) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Clinically significant change in body weight (kg) | 12 weeks |
| Change in blood insulin concentrations | Clinically significant change in blood insulin concentrations (μU/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laiko General Hospital of Athens | Athens | Attica | 11527 | Greece | ||
| Agricultural University of Athens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40017349 | Derived | Tsitsou S, Bali T, Adamantou M, Saridaki A, Poulia KA, Karagiannakis DS, Papakonstantinou E, Cholongitas E. Effects of a 12-Week Mediterranean-Type Time-Restricted Feeding Protocol in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Controlled Trial-The 'CHRONO-NAFLD Project'. Aliment Pharmacol Ther. 2025 Apr;61(8):1290-1309. doi: 10.1111/apt.70044. Epub 2025 Feb 28. |
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|
| Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Other | 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 |
|
| Hypocaloric Mediterranean Diet Without Time Restriction In Feeding | Other | 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 |
|
| 12 weeks |
| Change in Controlled Attenuation Parameter (CAP) | Clinically significant change in CAP (dB/m) | 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) | 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. | 12 weeks |
| Athens |
| Attica |
| 11855 |
| Greece |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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