Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD

Agricultural University of Athens

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding; Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05866744

HRBD40/27.04.2022 716/26-11-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Experimental group

Description:

Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet

Treatment:

Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Experimental group

Description:

Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet

Treatment:

Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Hypocaloric Mediterranean Diet Without Time Restriction In Feeding

Active Comparator group

Description:

Hypocaloric Mediterranean diet without time restriction in feeding

Treatment:

Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding