Clinical trial NCT05866744: Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD
Official title: Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients with Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Time-Restricted Feeding
Mediterranean Diet
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Laikο General Hospital, Athens
First posted: 2023-05-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index \>25 kg/m2
* Liver steatosis with Magnetic Resonance Elastography (MRE)

Exclusion Criteria:

* Other chronic liver diseases
* Alcohol consumption \>20 g/day (female) and \>30 g/day (male)
* Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
* Changes in body weight ± 3 % in the last 3 months
* Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
* Unstable glucose-lowering medications in the last 6 months
* Body weight lowering medications and/or history of bariatric surgery
* Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
* Uncontrolled type 2 diabetes mellitus defined as HbA1c value \> 9.0% or insulin depending type 1 and 2 diabetes mellitus
* Pregnancy
* Lactation
* Immunologic or inflammatory diseases
* Depression and other psychiatric diseases
* Patients working in shifts
* Cancer

Primary outcomes:
measure: Change in blood glucose concentrations
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
measure: Change in blood insulin concentrations
timeFrame: 12 weeks
measure: Change in Controlled Attenuation Parameter (CAP)
timeFrame: 12 weeks
measure: Change in blood lipids levels
timeFrame: 12 weeks
measure: Change in Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
References: