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'

Sofia Tsitsou; Triada Bali; Magdalini Adamantou; Aristi Saridaki; Kalliopi-Anna Poulia; Dimitrios S Karagiannakis; Emilia Papakonstantinou; Evangelos Cholongitas

doi:10.1111/apt.70044

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.

Authors

Sofia Tsitsou¹, Triada Bali², Magdalini Adamantou², Aristi Saridaki², Kalliopi-Anna Poulia¹, Dimitrios S Karagiannakis³, Emilia Papakonstantinou¹, Evangelos Cholongitas²

Affiliations

¹ Laboratory of Dietetics and Quality of Life, Department of Food Science and Human Nutrition, Agricultural University of Athens, Athens, Greece.
² First Department of Internal Medicine, Laiko General Hospital of Athens, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
³ Fourth Department of Internal Medicine, Attiko University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

Abstract

Background: The Mediterranean diet (MD) is considered the best dietary approach for patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Recently, time-restricted feeding (TRF) has gained attention for its lifestyle compatibility and health benefits.

Aims: This study aimed to compare the effects of a hypocaloric MD with a 10-h TRF protocol to an unrestricted MD in MASLD patients with overweight/obesity and evaluate differences between early and late TRF.

Methods: This 12-week randomised controlled trial in MASLD patients with overweight/obesity consisted of three groups, all following a hypocaloric Mediterranean-type diet. The control group had no eating time restrictions. The early TRF (eTRF) and late TRF (lTRF) groups had a 10-h eating window, from 8 AM to 6 PM and from 12 PM to 10 PM, respectively. Various health parameters were measured. Compliance was tracked via food diaries, and an 8-week follow-up occurred post-intervention.

Results: Fifty-nine MASLD individuals (27 males; 52.9 years; body mass index 32.1 kg/m²) completed the trial (control, n = 19; eTRF, n = 20; lTRF, n = 20). All groups showed significant 12-week reductions in body weight, anthropometry and blood pressure. Glycated haemoglobin A_1c and insulin resistance, as measured by the Matsuda index, homeostatic model assessment for insulin resistance and fasting glucose-to-insulin ratio, improved in the eTRF group at 12 weeks.

Conclusions: This study corroborates the efficacy of MD in ameliorating cardiometabolic risk factors such as body weight and blood pressure in MASLD patients. The combination with an eTRF protocol may improve glycaemic control (NCT05866744).

Trial registration: The study is registered at clinicaltrials.gov (NCT05866744).

Keywords: Mediterranean diet; glucose metabolism; insulin resistance; intermittent fasting; liver steatosis; metabolic dysfunction‐associated steatotic liver disease; time‐restricted feeding.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Body Mass Index
Diet, Mediterranean*
Female
Humans
Intermittent Fasting*
Male
Middle Aged
Non-alcoholic Fatty Liver Disease* / diet therapy
Obesity* / complications
Obesity* / diet therapy
Overweight / diet therapy
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05866744