Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding

• Registration Number: NCT05866744
• Lead Sponsor: Agricultural University of Athens

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.

Study Timeline

• Study First Submitted: 2023-03-30
• Study Start: 2023-05-08
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet	Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet	Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet	Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet	Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding	Hypocaloric Mediterranean Diet Without Time Restriction In Feeding	Hypocaloric Mediterranean diet without time restriction in feeding

Primary Outcome Measures

Name	Time	Method
Change in blood glucose concentrations	12 weeks	Clinically significant change in blood glucose concentrations (mg/dL)

Secondary Outcome Measures

Name	Time	Method
Change in body weight	12 weeks	Clinically significant change in body weight (kg)
Change in blood insulin concentrations	12 weeks	Clinically significant change in blood insulin concentrations (μU/L)
Change in Controlled Attenuation Parameter (CAP)	12 weeks	Clinically significant change in CAP (dB/m)
Change in blood lipids levels	12 weeks	Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)
Change in Chronic Liver Disease Questionnaire (CLDQ)	12 weeks	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.

Trial Locations

Locations (2)

Laiko General Hospital of Athens; 🇬🇷 Athens, Attica, Greece

Agricultural University of Athens; 🇬🇷 Athens, Attica, Greece